Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis (MINDFUL)

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Dietary Supplement: Psyllium Husk Powder; Drug: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03998488

19-04020045

5R01DK128257 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:

1. Investigational FMT (one-time)

   1. Subject will blindly receive investigational FMT once at day 0 colonoscopy
   2. Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.

2. Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks)

   1. Subject will blindly receive investigational FMT once at day 0 colonoscopy
   2. Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.

3. Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks)

   1. Subject will blindly receive placebo FMT once at day 0 colonoscopy
   2. Subjects in this group will blindly receive investigational FMP250 at week 8 by flexible sigmoidoscopy.

Subjects will blindly receive the investigational or placebo FMP250 treatment if they meet all inclusion and exclusion criteria during the day 0 screening colonoscopy. Subjects will receive follow-up phone calls at day 1, week 2, week 6, and week 10 post-FMT and will return for clinic visits at week 4, week 8 and week 12 post-FMT. Stool and blood samples will be collected for research purposes from subjects at every clinic visit (Day 0 colonoscopy, Week 4, Week 8, and Week 12). Mucosal biopsies will also be taken during the initial colonoscopy, at day 0 and during the follow-up flexible sigmoidoscopy at week 8. At week 8 post-FMT, all subjects will be evaluated by flexible sigmoidoscopy. Subjects originally randomized into the placebo cohort at week 0 will receive investigational FMP250 by flexible sigmoidoscopy at week 8, and subjects originally randomized into the investigational cohort at week 0 will receive placebo FMP250 by flexible sigmoidoscopy at week 8. Lastly, all subjects will be contacted for follow-up phone calls every subsequent 6 months for the next year.

Enrollment: 27 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female ≥ 18 years of age.

• Documentation of prior history of mild to moderate UC.

• Endoscopy confirmed active UC ≥ 15 centimeters at week 0 screening colonoscopy.

  a. As defined by a total Mayo scoring of 4-10 with an endoscopic sub-score ≥ 1.

• Patients must have a descending intact colon.

• Patients taking steroid or biologic therapy must be on a stable dose for 4 weeks prior to screening and maintained throughout the trial.

• Eligible patients willing to undergo screening testing prior to FMT to document baseline status:

  1. Urine Testing
  2. Blood Testing
  3. Stool Testing

• Patients must discontinue anti-rCDI antibiotics (e.g. vancomycin, fidaxomicin) 48 hours prior to FMT delivery procedure.

Exclusion criteria

• Biopsy proven Crohn's disease

• UC patients with severe disease (defined as a total mayo score >10)

• Clinical complications requiring emergent management (e.g. stricture, bowel obstruction, perforation and/or abscess)

• Concurrent C. difficile or other infections

• Primary sclerosing cholangitis

• Prior history of FMT

• Treatment for malignancy within past 5 years

• Active or latent tuberculosis

• Clinically meaningful laboratory abnormalities

  1. Hb: < 8
  2. ALT: greater than 3x the ULN (upper limit of normal)

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

• Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 3 patient groups, including a placebo group

Investigational FMT

Experimental group

Description:

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.

Treatment:

Drug: Fecal Microbiota Transplantation

Investigational FMT + psyllium fiber

Active Comparator group

Description:

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.

Treatment:

Drug: Fecal Microbiota Transplantation

Dietary Supplement: Psyllium Husk Powder

Placebo FMT +/- psyllium fiber

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Psyllium Husk Powder