Crohn's Disease · Ulcerative Colitis
Vedolizumab for Adults With Active Ulcerative Colitis or Crohn's Disease
This study examines symptom remission after intravenous and then subcutaneous vedolizumab in adults with moderately to severely active ulcerative colitis or Crohn's disease.
Registry title: A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
77 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Vedolizumab IV or Vedolizumab SC
- Design
- Non Randomized
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
Among adults with moderately to severely active ulcerative colitis or Crohn's disease treated with vedolizumab, what percentage have patient-reported symptom remission at week 14?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with moderately to severely active ulcerative colitis or Crohn's disease.
- The diagnosis must have been established before screening through clinical and endoscopic evidence and supported by a histopathology report.
- The study is looking for people who had an inadequate response, lost response, or could not tolerate at least one corticosteroid, immunomodulator, or advanced therapy.
- Study locations are listed in the United States, but the study team must confirm whether a particular site is currently enrolling.
Participation overview
What participation may involve
Participants receive vedolizumab infusions followed by under-the-skin injections, complete symptom and disease assessments, and return for follow-up after their last treatment. What participation may involve: - Receive 300 milligrams of vedolizumab by IV infusion at weeks 0 and 2, with a possible additional IV dose at week 6. - Transition to 108-milligram under-the-skin vedolizumab injections by week 14, generally given every two weeks through week 50. - Report symptoms used to assess remission and clinical response, including stool frequency, abdominal pain, and rectal bleeding as applicable to the participant's condition. - Complete assessments involving endoscopy, C-reactive protein, fecal calprotectin, and monitoring for serious infections. Vedolizumab treatment lasts approximately 50 weeks. Participants are checked again 18 weeks after their last treatment, and safety monitoring is reported through up to 72 weeks. The registry says participants visit the clinic several times but does not give a complete visit schedule. Participants who stop vedolizumab after week 14 have required visits at weeks 26 and 52.
Study interventions
What participants may receive or do
- Vedolizumab IV: Vedolizumab is given by intravenous (IV) infusion at weeks 0 and 2. The treating clinician may give another IV dose at week 6 before the required transition to subcutaneous treatment by week 14.
- Vedolizumab SC: Vedolizumab is given as a 108-milligram subcutaneous (under-the-skin) injection every two weeks after transition from IV treatment, continuing through week 50.
Study design
How the comparison works
This is a Phase 4 interventional study with separate ulcerative colitis and Crohn's disease groups. Both groups receive vedolizumab by IV infusion followed by under-the-skin injections. The study is non-randomized, so participants are not assigned to groups by chance. The study has no masking; participants and study personnel are not described as blinded to treatment. The registry lists no separate control or comparator group; both condition-specific groups receive vedolizumab.
Reported activities
Procedures and tests
- Intravenous vedolizumab infusions
- Subcutaneous vedolizumab injections
- Seven-day symptom reporting for stool frequency and abdominal pain for Crohn's disease, or stool frequency and rectal bleeding for ulcerative colitis
- Clinical disease-activity scoring using Crohn's Disease Activity Index or Mayo measures, depending on the condition
- Endoscopic assessments of Crohn's disease or ulcerative colitis at week 52
- Blood testing for C-reactive protein at baseline and weeks 6, 14, and 52
- Stool testing for fecal calprotectin at baseline and weeks 6, 14, and 52
- Monitoring for serious infections through the end of the study
- Screening confirmation of disease activity, prior clinical and endoscopic evidence, and a supporting histopathology report
- A urine pregnancy test within three days before the first vedolizumab dose for participants who are women of childbearing potential
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old when they sign informed consent.
- Immunizations must be up to date according to the U.S. prescribing information for vedolizumab.
- Crohn's disease must be moderately to severely active at screening, with a Crohn's Disease Activity Index score of 220 to 450 and a Simple Endoscopic Score for Crohn's Disease of at least 6, or at least 4 for isolated ileal disease.
- Ulcerative colitis must be moderately to severely active at screening, with a complete Mayo score of 6 to 12 and an endoscopy subscore of 2 to 3.
- The ulcerative colitis or Crohn's disease diagnosis must have been established before screening by clinical and endoscopic evidence and supported by a histopathology report.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, or advanced therapy.
- Participants with reproductive potential must follow the study's contraception and donation restrictions through at least 18 weeks after the last vedolizumab dose; additional pregnancy and breastfeeding requirements apply to women of childbearing potential.
Possible reasons someone may not be able to join
- Any previous treatment with an approved or investigational anti-integrin antibody, including vedolizumab, excludes participation.
- People who had primary or secondary nonresponse to more than two previous advanced treatments are excluded.
- Use of corticosteroid enemas or suppositories within two weeks before screening is not allowed.
- Contraindications or relevant warnings, interactions, special-population considerations, allergy, hypersensitivity, or intolerance related to vedolizumab may exclude participation in the investigator's opinion.
- Receipt of an investigational biologic within six months before screening is not allowed.
- An advanced treatment previously received for an approved condition other than ulcerative colitis or Crohn's disease excludes participation.
- Evidence of an active infection during screening excludes participation.
- An ileostomy, colostomy, severe or symptomatic intestinal narrowing, or short bowel syndrome excludes participation.
- A procedure requiring general anesthesia within three months before screening, or planned or likely major surgery during the study, excludes participation.
- Most histories of cancer exclude participation, although the registry lists specific exceptions and allows some remote histories to be reviewed individually with the sponsor.
- A history of or symptoms suggesting progressive multifocal leukoencephalopathy, in the investigator's opinion, excludes participation.
- Laboratory abnormalities during screening may exclude participation, but the registry does not specify which abnormalities or thresholds.
Important unknowns
What the record does not make clear
- The registry says there will be several clinic visits and identifies some assessment weeks, but it does not provide a complete visit-by-visit schedule.
- The registry does not state which current ulcerative colitis or Crohn's disease treatments may continue during the study.
- The registry gives timing restrictions for corticosteroid enemas or suppositories and investigational biologics but does not provide a complete medication washout plan.
- The registry says participants without adequate response after week 14 stop vedolizumab and may change treatment, but it does not identify the alternative or rescue-treatment options.
- Screening eligibility and week-52 outcomes use endoscopic findings, but the registry does not describe the exact endoscopy schedule, preparation, sedation, or whether prior results can be used.
- The registry does not explain which study treatments, tests, or routine-care expenses are paid by the sponsor or billed to insurance.
- The registry does not report whether participants receive compensation or reimbursement.
- The registry does not state whether transportation, lodging, parking, or other travel support is available.
- The registry does not state whether any visits or assessments can be completed remotely or through a local clinician.
- The registry does not explain whether or how participants may continue vedolizumab after study participation ends.
- The overall study is recruiting, but listed locations have different statuses, so availability must be confirmed with the selected site.
Before contacting the site
Questions for the study team
- What is the complete schedule of clinic visits, procedures, and time required at each visit?
- Which current ulcerative colitis or Crohn's disease medicines must continue, stop, or change during screening and treatment?
- What happens if symptoms worsen or vedolizumab has not worked adequately by week 14?
- Exactly which endoscopies are required, and what preparation, sedation, or recovery time do they involve?
- Which treatment, testing, travel, and routine-care costs are covered, and is reimbursement or compensation available?
- Is the nearest site currently enrolling for ulcerative colitis, Crohn's disease, or both?
- Which visits can be completed remotely or through my local gastroenterologist?
- What treatment and follow-up options are available after the final study visit?
Before changing care
Questions for your gastroenterologist
- How would screening or study treatment affect my current ulcerative colitis or Crohn's disease medicines?
- How stable is my disease now, and how do my recent symptom, endoscopy, and laboratory results compare with the study's screening requirements?
- What approved treatment alternatives should I understand before considering this study?
- What risks or monitoring concerns with vedolizumab are most relevant to my infections, surgeries, cancer history, allergies, and other health conditions?
- How should you and the research team coordinate if my symptoms worsen or vedolizumab is stopped?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- Vedolizumab-4063
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
UC Participants: Vedolizumab
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Interventions: Drug: Vedolizumab IV, Drug: Vedolizumab SC
Experimental
CD Participants: Vedolizumab
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
Interventions: Drug: Vedolizumab IV, Drug: Vedolizumab SC
Interventions
Drug
Vedolizumab IV
Vedolizumab IV infusion
Drug
Vedolizumab SC
Vedolizumab SC injection
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (17)
- In the investigator's opinion, the participant can understand and comply with protocol requirements.Registry-derived · unreviewed
- The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.Registry-derived · unreviewed
- The participant is 18 to 80 years of age at the time of signing the ICF.Registry-derived · unreviewed
- The participant's immunization is up to date per vedolizumab US prescribing information (USPI).Registry-derived · unreviewed
- If participant is a woman of childbearing potential (WOCBP):Registry-derived · unreviewed
- Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.Registry-derived · unreviewed
- Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.Registry-derived · unreviewed
- Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.Registry-derived · unreviewed
- Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.Registry-derived · unreviewed
- If participant is a fertile man:Registry-derived · unreviewed
- Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumabRegistry-derived · unreviewed
- Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.Registry-derived · unreviewed
- The participant has a diagnosis of moderate to severely active UC or CD defined by the following:Registry-derived · unreviewed
- CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening ORRegistry-derived · unreviewed
- UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screeningRegistry-derived · unreviewed
- UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.Registry-derived · unreviewed
- Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.Registry-derived · unreviewed
Exclusion criteria (12)
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening.Registry-derived · unreviewed
- Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.Registry-derived · unreviewed
- Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).Registry-derived · unreviewed
- In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).Registry-derived · unreviewed
- Received any investigational biologic therapy \<= 6 months prior to screening.Registry-derived · unreviewed
- The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).Registry-derived · unreviewed
- The participant has any evidence of an active infection during screening.Registry-derived · unreviewed
- Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.Registry-derived · unreviewed
- A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.Registry-derived · unreviewed
- History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.Registry-derived · unreviewed
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.Registry-derived · unreviewed
- Has laboratory abnormalities during the screening period.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
Time frame: At Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
Primary outcome
Percentage of UC Participants With PRO-2 Remission at Week 14
Time frame: At Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Secondary outcome
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Time frame: At Weeks 6 and 52
PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Secondary outcome
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52
Time frame: At Weeks 6, 14, and 52
CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point(s) or absolute rectal bleeding sub-score of \<=1 point or absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit.
Secondary outcome
Percentage of CD Participants With Endoscopic Response at Week 52
Time frame: At Week 52
Endoscopic response is defined as \>=50% reduction from baseline (or for participants with isolated ileal disease, SES-CD \<= 4 or at least a 2-point reduction from baseline) in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Secondary outcome
Percentage of CD Participants Achieving Endoscopic Remission at Week 52
Time frame: At Week 52
Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1. SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Secondary outcome
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
Time frame: At Week 52
Improvement of endoscopic appearance of the mucosa is defined as Mayo endoscopic sub-score = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]).
Secondary outcome
Percentage of UC Participants With Endoscopic Remission at Week 52
Time frame: At Week 52
Endoscopic remission is defined as a centrally read complete Mayo endoscopy subscore of 0.
Secondary outcome
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52
Time frame: At Weeks 6, 14, and 52
Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1.
Secondary outcome
Percentage of CD and UC Participants With Clinical Remission at Week 52
Time frame: At Week 52
Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.
Secondary outcome
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52
Time frame: Baseline, Weeks 6, 14, and 52
Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Secondary outcome
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52
Time frame: Baseline, Weeks 6, 14, and 52
Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Secondary outcome
Number of CD and UC Participants With Serious Infections
Time frame: Up to end of study (up to 72 weeks)
Number of CD and UC participants with serious infections will be reported.
Recruiting locations in the United States
Gastro Health
RecruitingBirmingham, Alabama, 35243, United States
Site Contact205-838-3823rshaffer@gastrohealth.com
Robert Shaffer
East View Medical Research
RecruitingMobile, Alabama, 36608, United States
Site Contact251-277-9090lhill@eastviewmr.com
Jonathan Siegel
AZ Gastro Care
RecruitingChandler, Arizona, 85225, United States
Site Contact480-393-0575squreshi@azgastrocare.com
Shahbaz Ali Qureshi
Spectrum Research Institute LLC
RecruitingGilbert, Arizona, 85297, United States
Site Contact480-801-9260donnad@sevalleygi.com
Donna DeSantis
GI Alliance- Sun City
RecruitingSun City, Arizona, 85351, United States
Site Contact623-972-2116ctrivedipi@arizonadigestivehealth.com
Chirag Trivedi
Gastroenterology and Liver Institute
RecruitingEscondido, California, 92025, United States
Site Contact808-469-0575drgara@giandliver.org
Naveen Gara
United Clinical Research Institute
RecruitingMurrieta, California, 92563, United States
Site Contact951-566-5229drhongpi@unitedmd.com
John Hong
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Site Contact719-310-6719bpatel@peakgastro.com
Bhaktasharan Patel
Rocky Mountain Endocopy Centers LLC
RecruitingLittleton, Colorado, 80120, United States
Site Contact303-722-8987rmg@jointopo.com
Erik Springer
Access Research Institute
RecruitingBrooksville, Florida, 34613, United States
Site Contact352-691-1140s.muddassir@ariinstitute.com
Salman Muddassir
Gastro Florida
RecruitingClearwater, Florida, 33762, United States
Site Contact727-336-7682lmweiss@gastrofl.com
Michael Weiss
Digestive and Liver Center of Florida, P.A.
RecruitingKissimmee, Florida, 34741, United States
Site Contact407-384-7388batiquzzaman@crosceola.com
Basher Atiquzzaman
Gastro Health Research - Miami
RecruitingMiami, Florida, 33176, United States
Site Contact786-539-3215jlopez@gastrohealth.com
Joanna Lopez
The Clinical Trials Network CTNX LLC
RecruitingOrange City, Florida, 32763, United States
Site Contact386-668-2221vishal.gupta@uniteddigestive.com
Vishal Gupta
Endoscopic Research, Inc.
RecruitingOrlando, Florida, 32803, United States
Site Contact407-896-1726ilaganeri@cdhfl.com
Marlon Ilagan
Orlando Health-Orlando Regional Medical Center
RecruitingOrlando, Florida, 32806, United States
Site Contact321-842-7900udayakumar.navaneethan@orlandohealth.com
Udayakumar Navaneethan
Gastro Health Research - Pensacola
RecruitingPensacola, Florida, 32504, United States
Site Contact850-436-4536fnewman@gastrohealth.com
Frederic Newman
West Central Gastroenterology d/b/a Gastro Florida
RecruitingPinellas Park, Florida, 33781, United States
Site Contact727-347-0005tglamour@gastrofl.com
Tejinder Glamour
AGA GA Research LLC
RecruitingAtlanta, Georgia, 30342, United States
Site Contact404-257-9000brett.mendel@atlantagastro.com
Justin Mendel
Digestive Healthcare of Georgia
RecruitingAtlanta, Georgia, 30327, United States
Site Contact404-355-3200mgalambos@yahoo.com
Michael Galambos
Yapp, Rockford M.D. (Private Practice)
RecruitingDowners Grove, Illinois, 60515, United States
Site Contact859-999-4506rgjsy34@aol.com
Rockford Yapp
GI Alliance - Glenview
RecruitingGlenview, Illinois, 60026, United States
Site Contact847-677-1170nmerel@illinoisgastro.com
Nina Merel
Gastroenterology and Internal Medicine Specialists, SC
RecruitingLake Barrington, Illinois, 60010, United States
Site Contact708-560-7299drbhuva@avicennaclinical.com
Manish Bhuva
GI Partners of Illinois - Southwest Gastroenterology
RecruitingOak Lawn, Illinois, 60453, United States
Site Contact708-253-5810drberkelhammer@avicennaclinical.com
Charles Berkelhammer
Rockford Gastroenterology Associates, Ltd.
RecruitingRockford, Illinois, 61107, United States
Site Contact815-397-7340drpatel@rockfordgi.com
Sunil Patel
Springfield Clinic
RecruitingSpringfield, Illinois, 62703, United States
Site Contact217-528-7541dshuster@springfieldclinic.com
Dmitry Shuster
Hutchinson Clinic
RecruitingHutchinson, Kansas, 67502, United States
Site Contact620-669-2500greenm@hutchclinic.com
Michael Green
Tri-State Gastroenterology Associates
RecruitingCrestview Hills, Kentucky, 41017, United States
Site Contact859-341-3575mjones-research@tsddc.com
Michael Jones
Baton Rouge General Medical Center - Bluebonnet Campus
RecruitingBaton Rouge, Louisiana, 70809, United States
Site Contact225-763-4828cchapman@tddctx.com
Jonathon Chapman
Combined Gastro LLC
RecruitingLafayette, Louisiana, 70503, United States
Site Contact337-235-9779jacque@gastroclinic.com
Jacque Noel
GI Alliance
RecruitingMetairie, Louisiana, 70006, United States
Site Contact504-456-8020catinis@metrogi.com
George Catinis
Portland Gastroenterology Center
RecruitingPortland, Maine, 04101, United States
Site Contact207-773-7964noemi.baffy@portlandgastro.com
Noemi Baffy
Capital Digestive Care
RecruitingChevy Chase, Maryland, 20815, United States
Site Contact301-841-6869erica.cohen@capitaldigestivecare.com
Erica Cohen
Woodholme Gastroenterology
RecruitingGlen Burnie, Maryland, 21061, United States
Site Contact410-783-8441woodholme@jointopo.com
Kenolisa Onwueme
Gastro Health Research - Framingham
RecruitingFramingham, Massachusetts, 01702, United States
Site Contact508-620-9200sfine@gastrohealth.com
Steven Fine
Lucida Clinical Trials LLC
RecruitingNew Bedford, Massachusetts, 02740, United States
Site Contact508-720-2015jreich@lucidaclinical.com
Jason Reich
Gastroenterology Associates of Western Michigan, P.L.C.
RecruitingWyoming, Michigan, 49519, United States
Site Contact616-328-5344acoates@gastro-assoc-wm.com
Allan Coates
Huron Gastro
RecruitingYpsilanti, Michigan, 48197, United States
Site Contact734-418-7736soofin@hurongastro.com
Najm Soofi
Delta Gastroenterology and Endoscopy Center
RecruitingSouthaven, Mississippi, 38671, United States
Site Contact662-280-8222uduncan@deltagastro.net
Ulric Duncan
SSM Health Medical Group
RecruitingBridgeton, Missouri, 63044, United States
Site Contact314-291-8824yezaz.ghouri@ssmhealth.com
Yezaz Ghouri
GI Associates Research, LLC
RecruitingColumbia, Missouri, 65201, United States
Site Contact573-740-0800michael.williams@objective.health
Michael Williams
Mid America Gastro Intestinal Consultants
RecruitingKansas City, Missouri, 64111, United States
Site Contact888-635-0552hillarybownik@cctdoctors.com
Hillary Bownik
St Charles Clinical Research
RecruitingWeldon Spring, Missouri, 63304, United States
Site Contact314-567-3377lw@gidoctor.net
Leonard Weinstock
Westchester Putnam Gastroenterology PC
RecruitingCarmel, New York, 10512, United States
Site Contact845-278-5223rperinbasekar@putnamgi.com
Rajiv Perinbasekar
Five Towns Gastroenterology
RecruitingCedarhurst, New York, 11516, United States
Site Contact516-374-5570marctfenster@gmail.com
Marc Fenster
IMIDeology
RecruitingElmhurst, New York, 11373, United States
Site Contact929-374-4054kevintin@yahoo.com
Kevin Tin
Intercity Gastroenterology
RecruitingFresh Meadows, New York, 11040, United States
Site Contact929-405-0165g.shahzad@synapsetrial.com
Ghulamullah Shahzad
New York Gastroenterology Associates
RecruitingNew York, New York, 10075, United States
Site Contact917-855-1993ana.tuyama@nygahealth.com
Ana Tuyama
ProHealth (Seaford) (Optum)
RecruitingSeaford, New York, 11783, United States
Site Contact516-796-9000cserer@prohealthcare.com
Corina Serer
Digestive Disease Medicine
RecruitingUtica, New York, 13502, United States
Site Contact315-624-7000harvey.allen@kinstonmd.com
Harvey Allen
Charlotte Gastroenterology and Hepatology, P.L.L.C
RecruitingCharlotte, North Carolina, 28207, United States
Site Contact704-375-9485gardiner.roddey@charlottegastro.com
John Gardiner Roddey
Carolina Digestive Diseases
RecruitingGreenville, North Carolina, 27834, United States
Site Contact252-758-8181pgoldstein@cddgastro.com
Phillip Goldstein
Piedmont Healthcare
RecruitingStatesville, North Carolina, 28625, United States
Site Contact404-605-2632brandon.marion@piedmonthealthcare.com
Brandon Marion
Wilmington Gastroenterology Associates
RecruitingWilmington, North Carolina, 28403, United States
Site Contact910-362-1011wking@trialmgt.com
William King
Gastro Health Research - Cincinnati
RecruitingCincinnati, Ohio, 45219, United States
Site Contact513-682-2892matkinson@gastrohealth.com
Matthew Atkinson
DSI Research Northridge LLC
RecruitingDayton, Ohio, 45414, United States
Site Contact937-469-8047rajeev.kurapati@objective.health
Rajeev Kurapati
Gastro Health Research - Liberty Township
RecruitingLiberty Township, Ohio, 45044, United States
Site Contact513-872-4549smartin@gastrohealth.com
Stephen Martin
Great Lakes Gastroenterology Research, LLC
RecruitingMentor, Ohio, 44060, United States
Site Contact440-205-1225kfriedenberg@thectnx.com
Keith Friedenberg
DSI Research LLC
RecruitingSpringboro, Ohio, 45066, United States
Site Contact937-293-2169anjali.morey@objective.health
Anjali Morey
NorthShore Gastroenterology Research, LLC
RecruitingWestlake, Ohio, 44145, United States
Site Contact440-250-7630kharris@northshoregastro.org
Kimberly Harris
The Oregon Clinic, P.C.
RecruitingPortland, Oregon, 97220, United States
Site Contact503-935-8322pkiyasu@orclinic.com
Phillip Kiyasu
University Gastroenterology
RecruitingProvidence, Rhode Island, 02904, United States
Site Contact401-227-8393lisa.mueller@gialliance.com
Lisa Mueller
Palmetto Primary Care Physician Division of Gastroenterology
RecruitingSummerville, South Carolina, 29486, United States
Site Contact843-376-0760bvanleer1@gmail.com
Brett Van Leer-Greenberg
Sanford Center for Digestive Health
RecruitingSioux Falls, South Dakota, 57105, United States
Site Contact605-328-8900ahmed.kurdi@sanfordhealth.org
Ahmed Kurdi
Tri-Cities Gastroenterology
RecruitingKingsport, Tennessee, 37663, United States
Site Contact423-279-1404gifry6@yahoo.com
Stephen Fry
The Clinical Trials Network CTNX LLC
RecruitingEl Paso, Texas, 79936, United States
Site Contact915-702-0165iegbuna.research@gastrocareep.com
Ikenna Egbuna
Amel Med LLC
RecruitingGeorgetown, Texas, 78628, United States
Site Contact512-593-6022masi.khaja@gmail.com
Masi Khaja
Kelsey Research Foundation
RecruitingHouston, Texas, 77005, United States
Site Contact713-442-1700sheela.chandra@kelsey-seybold.com
Sheela Chandra
MedCare Pharma LLC
RecruitingHouston, Texas, 77079, United States
Site Contact713-777-2776alan.glombicki@medcarepharama.care
Alan Glombicki
Spring Clinical Research
RecruitingHouston, Texas, 77090, United States
Site Contact832-885-7723sgorrela@springclinicalresearch.com
Sushma Gorrela
Gastro Health & Nutrition
RecruitingKaty, Texas, 77494, United States
Site Contact346-509-4141dverma@yourgastrohealth.com
Dharmendra Verma
One of a Kind Clinical Research Center LLC
RecruitingKingwood, Texas, 77339, United States
Site Contact713-704-6800sguha@hrgastro.com
Sushovan Guha
West Texas Research Institute
RecruitingLubbock, Texas, 79424, United States
Site Contact806-696-4440sameerislam@gastrosiresearch.com
Sameer Islam
Digestive Research of Central Texas, LLC
RecruitingWaco, Texas, 76712, United States
Site Contact940-222-6675hanumantha.ancha@objective.health
Hanumantha Ancha
GI Alliance - Webster
RecruitingWebster, Texas, 77598, United States
Site Contact281-480-6264sjafri@tddctx.com
Syed Jafri
Gastroenterology Consultants of Southwest Virginia.
RecruitingRoanoke, Virginia, 24014, United States
Site Contact540-345-4900nirishshah@gmail.com
Nirish Shah
GI Alliance
RecruitingBellevue, Washington, 98405, United States
Site Contact425-454-4768nprocaccini@washgi.com
Nicholas Procaccini
Central study contacts
Registry dates
- First posted
- Sep 3, 2024
- Primary completion
- Oct 1, 2027
- Overall completion
- Jun 1, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.