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 Title of Study: “A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: November 2022
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:
1. Investigational FMT (one-time)
2. Investigational FMT (one-time) + Psyllium (3x/day for 8 weeks)
3. Placebo FMT (one-time) + Psyllium (3x/day for 8 weeks) + open label FMT (one-time) a. Subjects in this group will be unblinded after the completion of their week 8 evaluation by flexible sigmoidoscopy and will consequently be given open label FMT.
Subjects will receive the investigational or placebo FMT treatment only if they meet all inclusion and exclusion criteria during the week 0 screening colonoscopy. Subjects will receive a follow-up phone call or return for a clinic visit every 2 weeks post-FMT until week 12. At week 8 post-FMT, all subjects will be evaluated by flexible sigmoidoscopy in the clinic. Stool and blood samples will be collected from subjects at week 0 prior to FMT, week 4 post-FMT, and week 8 post-FMT. Mucosal biopsies will also be taken during the initial colonoscopy at week 0 and during the follow-up flexible sigmoidoscopy at week 8. Subjects randomized into the placebo cohort will receive open-label investigational FMT by flexible sigmoidoscopy at the week 8 clinic visit (after week 8 endpoint data are collected). These subjects will return 4 weeks later at week 12 for a clinic visit. All subjects will be contacted for follow-up phone calls every subsequent 6 months for the next year.
- Drug: Fecal Microbiota Transplantation
- The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.
- Dietary Supplement: Psyllium Husk Powder
- All subjects assigned to the fiber treatment arms will be required to take 6g of psyllium husk powder twice per day for 4 weeks, beginning 3 days prior to week 0 screening colonoscopy. To simplify, enrolled participants will consume 10.2g of psyllium per day for 59 days. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Arms, Groups and Cohorts
- Experimental: Investigational FMT
- Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy.
- Active Comparator: Investigational FMT + psyllium fiber
- Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Participants will also receive fiber supplementation of 3.4g 3x/day for 8 weeks.
- Placebo Comparator: Placebo FMT + psyllium fiber
- Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. Participants will also receive fiber supplementation of 3.4g 3x/day for 8 weeks. Participants will be unblinded at their week 8 clinic visit after their endoscopic evaluation by flexible sigmoidoscopy and will receive open-label FMT.
Clinical Trial Outcome Measures
- Clinical Response
- Time Frame: Week 8 post-FMT
- Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by >3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point
- Clinical Remission
- Time Frame: Week 8 post-FMT
- Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore >1
- Endoscopic Response or Remission
- Time Frame: Week 8 post-FMT
- Endoscopic response or remission at week 8 post-FMT, as defined as a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0
Participating in This Clinical Trial
- Male or Female ≥ 18 years of age.
- Documentation of prior history of mild to moderate UC.
- Endoscopy confirmed active UC at week 0 screening colonoscopy.
a. As defined by a total Mayo scoring of 4-10 with an endoscopic sub-score of
- 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.
- Biopsy proven Crohn's disease
- UC patients with severe disease (defined as a total mayo score >10 or mayo endoscopic score of 3)
- 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
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 89 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Weill Medical College of Cornell University
- Crohn’s and Colitis Foundation
- Provider of Information About this Clinical Study
- Overall Official(s)
- Randy Longman, MD, PhD, Principal Investigator, Weill Medical College of Cornell University
- Overall Contact(s)
- Gabriela Funez-dePagnier, BS, 646-697-0985, email@example.com
Jacob V, Crawford C, Cohen-Mekelburg S, Viladomiu M, Putzel GG, Schneider Y, Chabouni F, OʼNeil S, Bosworth B, Woo V, Ajami NJ, Petrosino JF, Gerardin Y, Kassam Z, Smith M, Iliev ID, Sonnenberg GF, Artis D, Scherl E, Longman RS. Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis. Inflamm Bowel Dis. 2017 Jun;23(6):903-911. doi: 10.1097/MIB.0000000000001132.
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