Phase 2
N=27
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
Ulcerative Colitis · Inflammatory Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03998488 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Apr 2024
Primary outcome: Primary: Clinical Response — 5; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal Microbiota Transplantation (Drug); Psyllium Husk Powder (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response |
5; 2; 1 | — |
| SECONDARY Clinical Remission |
3; 1; 0 | — |
| SECONDARY Endoscopic Response or Remission |
4; 2; 0 | — |
| SECONDARY Number of Treatment or Disease Related Adverse Events. |
21; 33; 20 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03998488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.