Active Ulcerative Colitis (UC)
Enema vs Capsule Fecal Microbiota Transplantation for Active Ulcerative Colitis
This randomized pilot study is evaluating the safety, feasibility, and preliminary efficacy of fecal microbiota transplantation delivered by retention enema or oral capsules in adults with active ulcerative colitis.
Registry title: Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- PRIM-DJ2727 - FROZEN or PRIM-DJ2727 - CAPSULES
- Design
- Randomized
- Central study contact
- Herbert L DuPont, MD713 500 6687herbert.l.dupont@uth.tmc.edu
- Sponsor
- The University of Texas Health Science Center, Houston
Research question
How safe and feasible are frozen fecal microbiota transplantation by retention enema and lyophilized oral capsules for active ulcerative colitis, and what preliminary effects do they have on disease severity and the gut microbiome?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people with active ulcerative colitis defined by a Partial Mayo score of at least 3, with each subscore greater than 1.
- The study is looking for people able to take a retention enema and multiple oral capsules.
- Participants must be able to attend study clinic visits, assessments, and follow-up phone calls in Houston, Texas.
Participation overview
What participation may involve
Participants are randomly assigned to receive fecal microbiota transplantation as either an in-clinic frozen retention enema or enteric-coated oral capsules, followed by disease, microbiome, safety, quality-of-life, anxiety, and depression assessments. What participation may involve: - Receive an induction dose of donor-derived fecal microbiota transplantation by frozen retention enema or oral capsules. - Complete a Partial Mayo Score assessment of ulcerative colitis symptoms. - Provide material for fecal microbiota sequencing and analysis of antibody-coated microbiota. - Complete quality-of-life and anxiety and depression questionnaires. - Be monitored for adverse events through time points extending to six months after the last dose.
Study interventions
What participants may receive or do
- PRIM-DJ2727 - FROZEN: Participants assigned to this group receive an in-clinic induction dose of PRIM-DJ2727-FROZEN as a retention enema. The product is a saline-diluted, twice-filtered microbiota suspension made from 100 grams of stool from screened donors.
- PRIM-DJ2727 - CAPSULES: Participants assigned to this group receive an induction dose of PRIM-DJ2727-CAPSULES by mouth. The enteric-coated capsules contain microbiota from screened donors and are derived from 100 grams of stool.
Study design
How the comparison works
This is a Phase 1 pilot treatment study with an estimated 20 participants assigned in parallel to one of two experimental fecal microbiota transplantation formats. Participants are assigned randomly to the frozen-enema group or the capsule group; the registry does not report the assignment ratio. The study is open-label, meaning the registry reports no masking. The study compares two experimental delivery formats—frozen retention enema and oral capsules—and does not list a separate untreated or active-comparator group.
Reported activities
Procedures and tests
- Partial Mayo Score, a three-item ulcerative colitis disease-severity questionnaire scored from 0 to 9.
- Fecal microbiota sequencing to measure changes in microbial diversity and genera.
- Analysis of the proportion of antibody-coated microbiota using susceptibility testing or microbiota sequencing.
- Monitoring and assessment of adverse events.
- Short Inflammatory Bowel Disease Questionnaire, a 10-item quality-of-life assessment.
- Hospital Anxiety and Depression Scale, a 14-item questionnaire covering anxiety and depressive symptoms.
- For participants who could become pregnant, a urine human chorionic gonadotropin pregnancy test at enrollment and before treatment on Week 1, Day 1.
- Screening may involve confirming HIV, hepatitis B, hepatitis C, and absolute neutrophil count status because these are explicit exclusion criteria.
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
- Active ulcerative colitis must be diagnosed clinically, with a Partial Mayo score of at least 3 and every subscore greater than 1.
- Sexually active participants with reproductive potential must agree to use effective birth control during the study.
- Participants who could become pregnant must have negative urine pregnancy tests at enrollment and before study drug administration on Week 1, Day 1.
- Participants must be able and willing to give informed consent and attend all clinic visits, assessments, and follow-up phone calls.
- Participants must have an attending physician who will provide care unrelated to fecal microbiota transplantation.
Possible reasons someone may not be able to join
- People with severe ulcerative colitis, defined here as a Mayo score greater than 7, are excluded.
- People unable to take a retention enema or multiple oral capsules are excluded.
- People who are pregnant, breastfeeding, or planning pregnancy during the study are excluded.
- Receipt of systemic, non-topical antibiotics within 14 days before Treatment Day 1 is exclusionary.
- Active HIV, hepatitis B, or hepatitis C infection excludes participation.
- A history of recurrent Clostridium difficile infection or fecal microbiota transplantation within the past six months is exclusionary.
- Other active gastrointestinal conditions—including the listed bowel disorders, prior colostomy or colectomy, fistulas, strictures, chronic parasitic infections, or diverticulitis—are exclusionary.
- A compromised immune system is exclusionary, including clinical immunosuppression from a condition or medication such as more than 20 mg per day of prednisone or its equivalent.
- Active cancer or ongoing chemotherapy is exclusionary, except that superficial non-metastatic cancers and maintenance chemotherapy are permitted.
- Use of an investigational drug within 90 days before the screening visit is exclusionary.
- An absolute neutrophil count below 500 IU/mL is exclusionary.
Important unknowns
What the record does not make clear
- The registry requires clinic visits, assessments, and follow-up phone calls but does not give their number or complete schedule.
- Outcome measurements extend through six months after the last dose, but the registry does not state each participant's total participation period.
- The registry does not explain which ulcerative colitis treatments may be continued, adjusted, or prohibited during the study.
- A 14-day restriction is reported for systemic non-topical antibiotics, but washout requirements for other medications are not described.
- The registry does not describe rescue treatment if ulcerative colitis worsens during the study.
- The registry does not state whether colonoscopy, sigmoidoscopy, or another endoscopic procedure is required.
- The registry does not say which research or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry lists one Houston site but does not report reimbursement or support for travel, lodging, or parking.
- Follow-up phone calls are mentioned, but the registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to either fecal microbiota transplantation product after study participation ends.
- The registry describes an induction dose but refers elsewhere to an end of treatment and a last dose without reporting the full dosing schedule.
Before contacting the site
Questions for the study team
- How many fecal microbiota transplantation doses, clinic visits, assessments, and follow-up calls are required?
- Which current ulcerative colitis medicines may continue, and are any washout periods required beyond the 14-day systemic-antibiotic restriction?
- What happens if ulcerative colitis symptoms worsen, including what rescue treatment is allowed and when someone would stop study treatment?
- Are colonoscopy, sigmoidoscopy, biopsies, bowel preparation, blood draws, or stool collections required?
- What side effects or other risks are known for each delivery format, and how are participants monitored and treated if an adverse event occurs?
- Which costs are covered, is compensation offered, and is help available for travel or parking at the Houston site?
- Is the Houston site currently enrolling people into both the enema and capsule groups?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and how would the study's Partial Mayo score requirements relate to my recent disease activity?
- Would changing or pausing any of my current medicines for this study create concerns, and what approved treatment alternatives should I consider?
- Are there risks from donor-derived fecal microbiota transplantation that are especially relevant to my medical history, immune status, or current medications?
- What plan should be in place if my ulcerative colitis worsens while the research team is monitoring me?
- How should you and the research team coordinate my non-study care, test results, and medication decisions?
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
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Study design and administration
- Organization
- The University of Texas Health Science Center, Houston
- Organization class
- Other
- Organization study ID
- HSC-MS-23-0016
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Experimental: PRIM-DJ2727 - FROZEN
Interventions: Drug: PRIM-DJ2727 - FROZEN
Experimental
Experimental: PRIM-DJ2727 - CAPSULES
Interventions: Drug: PRIM-DJ2727 - CAPSULES
Interventions
Drug
PRIM-DJ2727 - FROZEN
Patients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose
Drug
PRIM-DJ2727 - CAPSULES
Patients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (5)
- Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1)Registry-derived · unreviewed
- Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.Registry-derived · unreviewed
- Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.Registry-derived · unreviewed
- Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.Registry-derived · unreviewed
- Subject has an attending physician who will provide the non-FMT care.Registry-derived · unreviewed
Exclusion criteria (15)
- Subjects with sever UC (Mayo score of \>7)Registry-derived · unreviewed
- Unable to take retention enema or multiple capsules orally.Registry-derived · unreviewed
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.Registry-derived · unreviewed
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.Registry-derived · unreviewed
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.Registry-derived · unreviewed
- History of recurrent Clostridium difficile infection or FMT in the past 6-months.Registry-derived · unreviewed
- History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.Registry-derived · unreviewed
- Known history of bile acid diarrheaRegistry-derived · unreviewed
- Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)Registry-derived · unreviewed
- History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).Registry-derived · unreviewed
- History of use of an investigational drug within 90 days prior to the screening visit.Registry-derived · unreviewed
- History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.Registry-derived · unreviewed
- Life expectancy of \< 1 year.Registry-derived · unreviewed
- In the opinion of investigator, subject for any reason, should be excluded from the study.Registry-derived · unreviewed
- Absolute neutrophil count (ANC) \< 500IU/mLRegistry-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
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
Time frame: week 5
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
Primary outcome
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline)
Primary outcome
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Time frame: Baseline,end of treatment (4 weeks after baseline)
Primary outcome
Safety as assessed by the adverse events
Time frame: 3 months after last dose
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Primary outcome
Safety as assessed by the adverse events
Time frame: 6 months after last dose
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Secondary outcome
Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time frame: baseline, week 5, early termination(if applicable)
This is a 10 item questionnaire and each is scored from 1(all of the time) to 7 (none of the time) for a maximum score of 70 a higher number indicating better quality of life
Secondary outcome
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, week 5, early termination(if applicable)
This is a fourteen-item questionnaire to assess anxiety and depression. Seven items are related to anxiety symptoms and seven to depressive symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, a higher number indicating worse outcome
Secondary outcome
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months
Secondary outcome
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months follow up
Recruiting locations in the United States
The University of Texas Health Science Center at Houston
RecruitingHouston, Texas, 77030, United States
Herbert L DuPont, MD713-500-9366herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH713 500 9371zhi-dong.jiang@uth.tmc.edu
Central study contacts
Registry dates
- First posted
- Mar 27, 2023
- Primary completion
- Dec 15, 2026
- Overall completion
- Dec 15, 2027
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.