Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis (MINDFUL)
Ulcerative Colitis, Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring FMT, Fecal Microbiota Transplantation, Inflammatory Bowel Diseases
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.
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Investigational FMT
Investigational FMT + psyllium fiber
Placebo FMT +/- psyllium fiber
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.