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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 July 2023
• Main ID: NCT03998488
• Date of registration: 24/06/2019
• Prospective Registration: Yes
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis MINDFUL
• Scientific 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
• Date of first enrolment: January 31, 2020
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03998488
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Randy Longman, MD, PhD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion 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:

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.



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Ulcerative Colitis

Intervention(s)

Drug: Fecal Microbiota Transplantation

Dietary Supplement: Psyllium Husk Powder

Primary Outcome(s)

Clinical Response [Time Frame: Week 8 post-FMT]

Secondary Outcome(s)

Endoscopic Response or Remission [Time Frame: Week 8 post-FMT]

Clinical Remission [Time Frame: Week 8 post-FMT]

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]

Number and type of treatment related adverse events. [Time Frame: Week 0 Colonoscopy - Week 12 post-FMT]

Secondary ID(s)

19-04020045

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Crohn's and Colitis Foundation