Clinical trial

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation

Name

STUDY-22-01753

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.

Trial arms

Trial start

2024-09-01

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Fecal Microbiota Transplant (FMT)

The intervention consists of the following steps: * Step 1: Vancomycin 125 mg orally every 6 hours and metronidazole 250 mg orally every 6 hours for 5 days. * Step 2: Bowel preparation with 10 ounces of magnesium citrate. * Step 3: Two FMT doses will be administered via enema one week apart using stool from donors with a durably healthy pouch.

Arms:

Fecal Microbiota Transplant (FMT)

Size

Primary endpoint

Number of patients with FMT related adverse events

8 weeks

Eligibility criteria

Inclusion Criteria: Patients age 18 or greater with UC who have undergone restorative proctocolectomy with ileal pouch anal anastomosis and have: * Chronic antibiotic dependent pouchitis: 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 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 * Subjects 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 subject at greater risk from FMT

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a pilot study of 16-18 patients who will each receive FMT.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-03-12

1 organization

1 product

2 indications

Organization

Maia Kayal

Product

Fecal Microbiota Transplant

Indication

Chronic Pouchitis

Indication

Pouchitis