Health TrialsbyHealthPanel

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

ConditionsChronic PouchitisPouchitis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaia Kayal

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics

Pre-pouch ileal inflammation, strictures, and/or fistulae, AND

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Fecal Microbiota Transplant (FMT)

    Drug

    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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Fecal Microbiota Transplant (FMT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with FMT related adverse events

The number of patients with FMT related adverse events through week 8 classified according to the Medical Dictionary for Regulatory Activities (MedDRA) and categorized according to the NIH Criteria for Adverse Events.

Time frame
8 weeks

Secondary outcomes

1

Number of patients in clinical remission

The number of patients in clinical remission assessed via patient interview and defined as mPDAI clinical subscore ≤4 points and no need for antibiotic therapy at week 8.

Time frame
8 weeks
2

Number of patients with endoscopic response

The number of patients with endoscopic response assessed via pouchoscopy and defined as a decrease from baseline in mPDAI endoscopic subscore \> 2 points at week 8.

Time frame
8 weeks
3

Change in recipient fecal microbial diversity via metagenomics analysis

The change in recipient fecal microbial diversity after FMT relative to baseline assessed via stool collection and using metagenomics analysis.

Time frame
Baseline and up to 8 weeks
4

Change in recipient fecal microbial diversity via strain strain isolation

The change in recipient fecal microbial diversity after FMT relative to baseline assessed via strain isolation - to isolate and sequence the gut microbial strains from each donor

Time frame
Baseline and up to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maia Kayal

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov
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