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

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Diseases

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Psyllium Husk Powder
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring FMT, Fecal Microbiota Transplantation, Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Investigational FMT

Investigational FMT + psyllium fiber

Placebo FMT +/- psyllium fiber

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Remission
Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore >1
Endoscopic Response or Remission
Endoscopic response or remission at week 8 post-FMT, as defined by a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0
Number and type of treatment related adverse events.
Change in Number of disease-related complications such as hospitalizations, surgeries and endoscopies, medical complications, and mortality

Full Information

First Posted
June 24, 2019
Last Updated
July 6, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Crohn's and Colitis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03998488
Brief Title
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
Acronym
MINDFUL
Official Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
June 9, 2023 (Actual)
Study Completion Date
July 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Crohn's and Colitis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments: Investigational FMT (one-time) Subject will blindly receive investigational FMT once at day 0 colonoscopy Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy. Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks) Subject will blindly receive investigational FMT once at day 0 colonoscopy Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy. Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks) Subject will blindly receive placebo FMT once at day 0 colonoscopy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Diseases
Keywords
FMT, Fecal Microbiota Transplantation, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blinded study
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational FMT
Arm Type
Experimental
Arm 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.
Arm Title
Investigational FMT + psyllium fiber
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo FMT +/- psyllium fiber
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
FMP250, FMT
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium Husk Powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Response
Description
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
Time Frame
Week 8 post-FMT
Secondary Outcome Measure Information:
Title
Clinical Remission
Description
Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore >1
Time Frame
Week 8 post-FMT
Title
Endoscopic Response or Remission
Description
Endoscopic response or remission at week 8 post-FMT, as defined by a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0
Time Frame
Week 8 post-FMT
Title
Number and type of treatment related adverse events.
Time Frame
Week 0 Colonoscopy - Week 12 post-FMT
Title
Change in Number of disease-related complications such as hospitalizations, surgeries and endoscopies, medical complications, and mortality
Time Frame
Week 0 Colonoscopy - Week 12 post-FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Urine Testing Blood Testing 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Longman, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28445246
Citation
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.
Results Reference
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Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

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