Crohn Disease
Microbiota Transplant Capsules for Crohn’s Disease
This study is investigating how two encapsulated fecal microbiota transplant products engraft in the intestines of adults with active Crohn’s disease and exploring associated microbial, symptom, endoscopic, and safety outcomes.
Registry title: Standardized Microbiota Transplant Therapy in Crohn's Disease
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–89 Years
- Treatment
- MTP-101C or MTP-101S
- Design
- Randomized · Double
- Central study contact
- Byron Vaughn612-624-0223bvaughn@umn.edu
- Sponsor
- University of Minnesota
Research question
Can MTP-101C and MTP-101S donor microbiota engraft in the ileum and colon of people with Crohn’s disease, and how does Crohn’s phenotype relate to engraftment?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 89 with Crohn’s disease diagnosed from typical clinical and tissue findings.
- The study is looking for people with active Crohn’s disease seen during endoscopy, with specified minimum Simple Endoscopic Score for Crohn’s Disease values.
- The study is looking for people whose current Crohn’s therapies are in maintenance dosing at randomization.
- Ongoing Crohn’s therapies other than steroids must generally be stable for four weeks before randomization and remain stable during the study.
- The listed study locations are in Minneapolis, Minnesota, and New York City, with different recruitment statuses.
Participation overview
What participation may involve
Participants may be randomized to MTP-101C or MTP-101S and undergo intestinal, stool, symptom, endoscopic, and safety assessments. What participation may involve: - Take the assigned encapsulated donor-microbiota product, MTP-101C or MTP-101S. - Provide ileal biopsy samples used to assess donor microbial engraftment and changes in microbial composition. - Provide colonic biopsy samples used to assess donor-microbiota engraftment and microbial changes. - Provide fecal samples for measuring engraftment during the study period. - Complete Crohn’s disease symptom assessments using the Crohn’s Disease Activity Index at baseline, two months, and six months. - Have endoscopic inflammation assessed with the Simple Endoscopic Score for Crohn’s Disease at baseline and two months. - Have adverse events and serious adverse events monitored to assess safety and tolerability.
Study interventions
What participants may receive or do
- MTP-101C: A double-encapsulated, freeze-dried preparation of healthy-donor microbiota. The registry states that each hypromellose capsule contains between 1 × 10^11 and 2 × 10^11 bacterial cells.
- MTP-101S: A healthy-donor microbiota preparation placed in double-encapsulated hypromellose capsules designed to disintegrate in the upper small bowel. The registry states that each capsule contains between 1 × 10^11 and 2 × 10^11 bacterial cells.
Study design
How the comparison works
This is a phase 2 interventional study with two parallel experimental groups comparing MTP-101C and MTP-101S. Participants are randomly assigned to the MTP-101C group or the MTP-101S group. The study is described as double-masked: participants and outcome assessors are masked. The two listed experimental groups receive different encapsulated donor-microbiota products and are compared in parallel.
Reported activities
Procedures and tests
- Ileal biopsies are used to measure donor microbial engraftment.
- Ileal biopsy samples are compared between baseline and two months for changes in microbial composition.
- Colonic biopsies are used to assess donor-microbiota engraftment.
- Fecal samples are used to measure engraftment over the study period.
- The Crohn’s Disease Activity Index is measured at baseline, two months, and six months.
- The Simple Endoscopic Score for Crohn’s Disease is measured at baseline and two months.
- Adverse events and serious adverse events are recorded to assess safety and tolerability.
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 able and willing to give informed consent.
- Participants must be 18 through 89 years old.
- Participants must speak English.
- A Crohn’s disease diagnosis must be based on typical clinical and tissue findings.
- Endoscopy must show active disease, with a Simple Endoscopic Score for Crohn’s Disease of at least 6, or at least 4 for isolated ileal disease.
- Current Crohn’s disease therapies must be in the maintenance phase of dosing at randomization.
- Except for steroids, ongoing Crohn’s therapy must be stable for four weeks before randomization and remain stable during the study.
- Steroid use must be 20 mg or less by five days before randomization; prednisone must then be tapered below 20 mg after seven days.
- People who could become pregnant must remain abstinent or use a highly effective form of birth control as specified by the registry.
Possible reasons someone may not be able to join
- People with extensive bowel resection, including subtotal colectomy or substantial small-bowel removal raising concern for short bowel syndrome, are excluded.
- A symptomatic stricture is exclusionary if it cannot be crossed by the colonoscope, requires intervention to cross, or is judged to cause the predominant clinical picture.
- People with an ileostomy, colostomy, or bowel-to-bladder fistula are excluded.
- Active or untreated infection excludes participation.
- Antibiotic use within 14 days before randomization is exclusionary.
- Current pregnancy, current breastfeeding, or plans to breastfeed during the study are exclusionary.
- People with end-stage liver disease or cirrhosis are excluded.
- An anticipated need for antibiotics or surgery during the study period is exclusionary.
- An absolute neutrophil count below 500 cells per microliter is exclusionary.
- Primary immunodeficiency is exclusionary.
- Active malignancy requiring chemotherapy is exclusionary, except for localized non-melanoma skin cancers; active cytotoxic cancer therapy is also excluded.
- A solid-organ transplant within six months, or CAR T-cell therapy or hematopoietic cell transplant within 12 months, is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not provide the number, timing, or format of study visits.
- Outcomes are reported through six months, but the registry does not explicitly state each participant’s total participation duration.
- The registry lists two experimental microbiota-product groups but does not explicitly discuss placebo use or placebo probability.
- The registry requires most ongoing Crohn’s therapies to remain stable and gives steroid rules, but it does not fully describe how every background treatment will be managed.
- The registry reports a 14-day antibiotic restriction and stability requirements for Crohn’s therapies but does not provide a complete washout list for other medications.
- The registry reports endoscopic assessments and intestinal biopsies but does not fully describe the procedures, preparation, sedation, or number of endoscopies.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, or other travel.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to MTP-101C or MTP-101S after study participation ends.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including screening, treatment, endoscopy, biopsy, stool collection, and follow-up visits?
- How are MTP-101C and MTP-101S taken, including the number of capsules, dosing days, and any preparation instructions?
- How many endoscopies and intestinal biopsies are required, and what preparation, sedation, and recovery should participants expect?
- Which current Crohn’s medicines may continue, and how are steroid tapering or rescue steroid courses coordinated with the study?
- Is there a placebo component, and what is the assignment probability for each group?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Is the site nearest me currently enrolling, and can any part of participation occur remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and how does that compare with the study’s endoscopic activity requirements?
- Could my current Crohn’s medicines remain stable as the protocol requires, and what concerns would you have about the steroid rules?
- What approved treatment alternatives should I understand while considering whether to contact this study?
- What risks or practical concerns might intestinal biopsies, repeated endoscopy, or donor-microbiota capsules pose in my clinical situation?
- How should my gastroenterology team and the research team coordinate routine treatment, rescue steroids, infections, antibiotics, and possible procedures?
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
Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.
Study design and administration
- Organization
- University of Minnesota
- Organization class
- Other
- Organization study ID
- GI-2024-33127
- Lead sponsor
- University of Minnesota
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Basic Science
- Masking
- Double
- Who is masked
- Participant, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
CD patients randomized to MTP-101C
Interventions: Biological: MTP-101C
Experimental
CD patients randomized to MTP-101S
Interventions: Biological: MTP-101S
Interventions
Biological
MTP-101C
MTP-101C composed of double-encapsulated freeze-dried healthy donor microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and double encapsulated into hypromellose capsules (Lonza, Morristown, NJ). Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.
Biological
MTP-101S
MTP-101S contains identical healthy donor microbiota double encapsulated in VCaps Plus (Lonza). These capsules are also composed of hypromellose but disintegrate in the proximal small bowel. Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.
Eligibility
18 Years–89 Years
All
Not accepted
Inclusion criteria (17)
- Able and willing to provide informed consent.Registry-derived · unreviewed
- 18-89 years of age.Registry-derived · unreviewed
- English speaking.Registry-derived · unreviewed
- Diagnosis of CD based on typical clinical and histologic features.Registry-derived · unreviewed
- Active disease on endoscopy:Registry-derived · unreviewed
- SES-CD \>= 6Registry-derived · unreviewed
- SES-CD \>= 4 for isolated ileal diseaseRegistry-derived · unreviewed
- Current CD therapies are in the maintenance phase of dosing at the time of randomization.Registry-derived · unreviewed
- Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.Registry-derived · unreviewed
- Steroid use 20mg or less by 5 days prior to randomization.Registry-derived · unreviewed
- Steroid use stipulations:Registry-derived · unreviewed
- Prednisone must be tapered below 20mg after 7 days.Registry-derived · unreviewed
- Any use of budesonide over the study period is allowed although tapering is encouraged.Registry-derived · unreviewed
- Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider.Registry-derived · unreviewed
- Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device).Registry-derived · unreviewed
- o Periodic abstinence and early withdraw are not acceptable methods.Registry-derived · unreviewed
- Able to comply with study measures in the opinion of the investigator.Registry-derived · unreviewed
Exclusion criteria (27)
- Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.Registry-derived · unreviewed
- Documented gastroparesisRegistry-derived · unreviewed
- History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.Registry-derived · unreviewed
- Symptomatic stricture defined as a stricture that:Registry-derived · unreviewed
- Cannot be traversed by the colonoscope,Registry-derived · unreviewed
- Requires intervention to be traversed,Registry-derived · unreviewed
- Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.Registry-derived · unreviewed
- Presence of ileostomy or colostomy.Registry-derived · unreviewed
- Entero-vesicular fistula (i.e., fistula from bowel to bladder).Registry-derived · unreviewed
- Suspicion of ischemic colitis, radiation colitis or microscopic colitis.Registry-derived · unreviewed
- Diagnosis of ulcerative colitis.Registry-derived · unreviewed
- Active or untreated infection.Registry-derived · unreviewed
- Adenomatous polyps that have not been removed.Registry-derived · unreviewed
- Use of antibiotics within 14-days of randomization.Registry-derived · unreviewed
- Current pregnancy.Registry-derived · unreviewed
- Current breastfeeding or planning to breastfeed over the study period.Registry-derived · unreviewed
- History of anaphylactic food allergies.Registry-derived · unreviewed
- End stage liver disease or cirrhosis.Registry-derived · unreviewed
- Anticipated need for antibiotics over the study period.Registry-derived · unreviewed
- Anticipated surgical procedure over the study period.Registry-derived · unreviewed
- An absolute neutrophil count \<500 cell/µL.Registry-derived · unreviewed
- Diagnosis of a primary immunodeficiency.Registry-derived · unreviewed
- Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).Registry-derived · unreviewed
- Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.Registry-derived · unreviewed
- Any solid organ transplant within 6 months of randomization.Registry-derived · unreviewed
- Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 monthsRegistry-derived · unreviewed
- Life expectancy \<=6 months.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
donor microbial engraftment
Time frame: 2months
measured in intestinal ileal biopsies
Secondary outcome
Changes in ileal microbial composition
Time frame: 2 months
biopsy samples, between baseline and 2 months
Secondary outcome
Colonic engraftment of donor microbiota
Time frame: 2 months
colonic biopsies
Secondary outcome
Changes in colonic microbial composition
Time frame: 2 months
Secondary outcome
Engraftment
Time frame: 2 months
measured by fecal samples over the study period.
Secondary outcome
Microbial compositional changes
Time frame: 2 months
Secondary outcome
Changes in clinical symptoms
Time frame: baseline, 2 months, 6 months
measured by the Crohn's Disease Activity Index (CDAI) at baseline, 2-months, and 6-months.
Secondary outcome
Endoscopic changes in inflammation
Time frame: 2 months
measured by the Single Endoscopic Score for Crohn's Disease (SES-CD) at baseline and 2-months.
Secondary outcome
Safety and tolerability of MTT
Time frame: 2 months
measured by the rate of AEs and SAEs.
Recruiting locations in the United States
University of Minnesota
RecruitingMinneapolis, Minnesota, 55414, United States
Byron Vaughnbvaughn@umn.edu
NYU Langone Health
Not Yet RecruitingNew York, New York, 10016, United States
Nathasha Melukkaran646-754-3433Nathasha.Melukkaran@nyulangone.org
Central study contacts
Registry dates
- First posted
- Oct 8, 2024
- Primary completion
- Jun 15, 2029
- Overall completion
- Jun 15, 2029
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.