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

NCT03998488 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 19-040200455R01DK128257
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

FMT; Fecal Microbiota Transplantation; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  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

  Week 8 post-FMT

Secondary Outcomes (3)

• Clinical Remission

  Week 8 post-FMT

• Endoscopic Response or Remission

  Week 8 post-FMT

• Number of Treatment or Disease Related Adverse Events.

  Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT

Study Arms (3)

Investigational FMT

EXPERIMENTAL

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.

Drug: Fecal Microbiota Transplantation

Investigational FMT + psyllium fiber

ACTIVE COMPARATOR

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.

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

Placebo FMT +/- psyllium fiber

PLACEBO COMPARATOR

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.

Dietary Supplement: Psyllium Husk Powder

Interventions

Fecal Microbiota Transplantation DRUG

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.

Also known as: FMP250, FMT

Investigational FMT; Investigational FMT + psyllium fiber

Psyllium Husk Powder DIETARY_SUPPLEMENT

All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.

Investigational FMT + psyllium fiber; Placebo FMT +/- psyllium fiber

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Hb: \< 8
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Crohn's and Colitis Foundation: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (2)

• Jacob V, Crawford C, Cohen-Mekelburg S, Viladomiu M, Putzel GG, Schneider Y, Chabouni F, O'Neil 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.

  PMID: 28445246 BACKGROUND

• Gogokhia L, Tran N, Grier A, Nagayama M, Xiang G, Funez-dePagnier G, Lavergne A, Ericsson C, Ben Maamar S, Zhang M, Battat R, Scherl E, Lukin DJ, Longman RS. Donor composition and fiber promote strain engraftment in a randomized controlled trial of fecal microbiota transplant for ulcerative colitis. Med. 2025 Sep 12;6(9):100707. doi: 10.1016/j.medj.2025.100707. Epub 2025 Jun 2.

  PMID: 40460824 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Randy Longman
• Organization: Weill Cornell Medicine

ral2006@med.cornell.edu

646-962-6289

Study Officials

• Randy Longman, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be randomly assigned to one of the three (Placebo or Investigational FMT +/- Psyllium) treatment groups. A series of randomized blocks of 6-10 will be generated with a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: January 31, 2020
• Primary Completion: June 9, 2023
• Study Completion: April 12, 2024
• Last Updated: January 3, 2025
• Results First Posted: April 2, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)