FMT + Dietary Fiber for Ulcerative Colitis
(MINDFUL Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRandy Longman, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.

Eligibility Criteria

Adults with mild to moderate Ulcerative Colitis confirmed by endoscopy can join this trial. They must have a stable dose of steroids or biologics for 4 weeks before and during the study, undergo baseline health tests, and stop certain antibiotics 48 hours before treatment. People with severe UC, Crohn's disease, recent cancer treatments, tuberculosis, significant lab abnormalities or allergies to psyllium husk cannot participate.

Inclusion Criteria

I have a history of mild to moderate ulcerative colitis.

I am willing to have urine, blood, and stool tests before treatment.

I am 18 years old or older.

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Exclusion Criteria

Clinically meaningful laboratory abnormalities: Hb: < 8, ALT: greater than 3x the ULN (upper limit of normal)

History of anaphylactic reactions to food allergens or allergy to psyllium husk

I have been diagnosed with primary sclerosing cholangitis.

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Treatment Details

Interventions

Fecal Microbiota Transplantation (Microbiome Therapy)
Psyllium Husk Powder (Dietary Supplement)

Trial OverviewThe trial is testing if Fecal Microbiota Transplantation (FMT) combined with high fiber from Psyllium Husk Powder helps patients with Ulcerative Colitis. Participants are randomly assigned to receive either the real treatments or placebos without knowing which one they're getting.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Investigational FMTExperimental Treatment1 Intervention

Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy.

Group II: Investigational FMT + psyllium fiberActive Control2 Interventions

Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy.

Group III: Placebo FMT +/- psyllium fiberPlacebo Group1 Intervention

Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fecal Microbiota Transplantation for: