Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Maia Kayal

Status and phase

Enrolling

Early Phase 1

Conditions

Pouchitis

Chronic Pouchitis

Treatments

Drug: Fecal Microbiota Transplant (FMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05829109

STUDY-22-01753

Details and patient eligibility

About

The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.

Full description

The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis. FMT has been successfully used in the treatment of recurrent Clostridiodes difficile infection and has shown benefit in the treatment of ulcerative colitis in clinical trials. The success of FMT in these patients is because of the reconstitution of the recipient's unhealthy gut bacteria with the donor's healthy gut bacteria.

Surgery to remove the colon is required in a subset of patients with ulcerative colitis that does not respond to medical therapy. In these patients, an internal pouch is created from small intestine to function as a stool reservoir and avoid an ostomy after the colon is removed. Inflammation of the pouch, pouchitis, is common after surgery and can manifest as diarrhea, pelvic pain, urgency and blood in the stool. Chronic pouchitis occurs in up to 20% of patients and there is no approved treatment. A number of studies have evaluated FMT in patients with chronic pouchitis, but have proven unsuccessful. This is likely because these studies have used stool from patients with a colon and transplanted it into patients with a pouch. This is problematic because the gut bacteria of the colon and pouch are not similar, and putting healthy stool from a colon may not reconstitute a healthy pouch microbiome. The specific purpose of this project is to transplant stool from patients with a healthy pouch to patients with an inflamed pouch.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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