NCT03998488CompletedPhase 2
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 3 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 24 Jun 2019
- Start date
- 31 Jan 2020
- Primary completion date
- 9 Jun 2023
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Ulcerative colitis
- NCT number
- NCT03998488
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 27
- From 31 Jan 2020 to the primary completion date, 9 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent C. difficile or other infections
- Prior history of FMT
Other illness
- 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)
- Treatment for malignancy within past 5 years
- Active or latent tuberculosis
- 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.
Lab values
- Clinically meaningful laboratory abnormalities
- Hb: \< 8
- ALT: greater than 3x the ULN (upper limit of normal)
Other
- Primary sclerosing cholangitis
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.