Low Sulfur Fecal Transplant for Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT03948919|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Fecal microbiota Other: Placebo||Phase 1|
Inflammatory bowel disease (IBD) is a chronic, relapsing remitting inflammatory disease of the intestine. The two main forms of IBD are Crohn's disease (CD) and Ulcerative Colitis (UC). There is no cure for IBD and the etiology is unknown, however IBD is thought to arise as an aberrant immune response to the intestinal microbiota. The intestinal microbiota closely correlates with inflammation in IBD. Currently, the treatment of IBD is based on suppressing the aberrant immune response in the intestine. This often takes the form of systemic immunosuppression, which in turn carries a multitude of risks including infection and malignancy. Thus there is an urgent need for safe, effective therapies that ultimately have the potential to cure IBD.
Fecal microbiota transplantation (FMT) is the process of transferring fecal microbiota from one individual to another. FMT has revolutionized the treatment of multiple recurrent Clostridium difficile infection with a cure rate around 90%. Given the success of FMT in C. difficile colitis, attention turned to other forms of colitis, in particular IBD. Early pilot studies demonstrated a mixed result for the use of FMT in IBD. One of the key issues surrounding the use of FMT in IBD is the challenge of engrafting a new microbiota. Additionally IBD flares following FMT for C. difficile infection have been reported, although it is difficult to account for the confounding of the underlying C. difficile infection. This study will examine how FMT donor selection can impact the engraftment of the microbiota into patients with UC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Low Sulfur Fecal Transplant for Ulcerative Colitis|
|Actual Study Start Date :||July 31, 2019|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: FMT Treatment
Fecal microbiota - 1.0-3.0 x 10^11 CFU / day (2 capsules per day for 8 weeks).
Drug: Fecal microbiota
Lyophilized encapsulated fecal microbiota given daily for 8 weeks.
Placebo Comparator: Placebo
The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product. Two capsules taken daily for 8 weeks.
Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.
- Engraftment of low sulfate reducing microbiota [ Time Frame: 12 weeks ]Change in quantitative PCR of sulfate reducing genes from baseline to week 12 between FMT arm and placebo arm.
- Rate of change of sulfate reducing microbiota [ Time Frame: 4 weeks ]Change in quantitative PCR of sulfate reducing genes at week 1, 2, 3 and 4 between FMT arm and placebo arm
- Clinical efficacy of FMT versus placebo [ Time Frame: 8 weeks ]Change in partial Mayo score from baseline to week 8 between FMT and placebo arm
- Clinical efficacy of low sulfate reducing microbiota [ Time Frame: 12 weeks ]Partial mayo score at week 12 between those with low sulfate reducing microbiota or not low sulfate reducing microbiota
- Serious adverse events [ Time Frame: 12 weeks ]Number of serious adverse events between FMT arm and placebo arm
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|Ages Eligible for Study:||18 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Able and willing to provide consent
- English speaking
- Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis
- Diagnosis of ulcerative colitis > 3 months
- Active disease on endoscopy (endoscopic Mayo subscore ≥ 1)
- Evidence of inflammation extending beyond a minimum of 20cm
- Any ongoing ulcerative colitis therapy must be at stable doses for 4 weeks prior to study and remain stable over the course of the study
- Extensive bowel resection
- Presence of ileostomy or colostomy
- Suspicion of ischemic colitis, radiation colitis or microscopic colitis
- Diagnosis of Crohn's disease
- Diagnosis of per-anal fistula or abscess
- Adenomatous polyps that have not been removed
- Use of pre or probiotics within 30 days of randomization
- Severe food allergies
- End stage liver disease or cirrhosis
- An absolute neutrophil count < 500 cell/µL
- Life expectancy < 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948919
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Byron Vaughn, MD||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||May 14, 2019 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Diseases
Inflammatory Bowel Diseases