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New treatment option for Chronic Pouchitis
Official title Fecal Microbiota Transplant for Patients With Chronic Pouchitis
ClinicalTrials.gov ID: NCT05829109
What this study is testing
What is Fecal Microbiota Transplant (FMT)?
Fecal Microbiota Transplant (FMT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic pouchitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as:
- Chronic antibiotic dependent pouchitis:
- The need for continuous antibiotic therapy (\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to...
- Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months
- Chronic antibiotic refractory pouchitis:
You likely can't join if
- Patients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:
- Allergy to vancomycin, metronidazole, or ingredients present in the FMT
- Women who are breastfeeding
- Women who are pregnant
- Participants with fever \> 100.4F/38C or other signs of active illness
- Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)
See the full eligibility criteria
- Patients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as:
- Chronic antibiotic dependent pouchitis:
- The need for continuous antibiotic therapy (\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes, OR
- Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months
- Chronic antibiotic refractory pouchitis:
- Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics
- Crohn's disease like pouch inflammation on biologic or small molecule therapy with persistent symptoms:
- Pre-pouch ileal inflammation, strictures, and/or fistulae, AND
- Active biologic or small molecule therapy, AND
- Persistent symptoms with mPDAI clinical sub-score ≥ 2
- Patients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:
- Allergy to vancomycin, metronidazole, or ingredients present in the FMT
- Women who are breastfeeding
- Women who are pregnant
- Participants with fever \> 100.4F/38C or other signs of active illness
- Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)
- Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids or any investigational drugs
- Crohn's disease like pouch inflammation
- Active enteric infection
- Isolated cuffitis
- Clinically significant strictures of the pouch inlet or outlet
- Participation in a clinical trial in the preceding 30 days
- Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines will put the participant at greater risk from FMT
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.