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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
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date February 8, 2023
Actual Study Start Date  ICMJE July 31, 2019
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Low Sulfur Fecal Transplant for Ulcerative Colitis
Official Title  ICMJE Low Sulfur Fecal Transplant for Ulcerative Colitis
Brief Summary The purpose of this study is to evaluate the engraftment of donor microbiota's sulfate reducing bacteria (SRB) in subjects with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). Specifically this study will evaluate if low SRB donor microbiota translates to lower SRB microbiota in the UC recipient. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. Patients with UC have a higher relative abundance of SRB compared to healthy controls. It is the aim of this study to determine if the microbiota in UC can be altered to favor a low SRB fraction.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Fecal microbiota
    Lyophilized encapsulated fecal microbiota given daily for 8 weeks.
  • Other: Placebo
    Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.
Study Arms  ICMJE
  • Active Comparator: FMT Treatment
    Fecal microbiota - 1.0-3.0 x 10^11 CFU / day (2 capsules per day for 8 weeks).
    Intervention: Drug: Fecal microbiota
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnancy
  • Severe food allergies
  • End stage liver disease or cirrhosis
  • An absolute neutrophil count < 500 cell/µL
  • Life expectancy < 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03948919
Other Study ID Numbers  ICMJE GI-2019-27285
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Byron Vaughn, MD University of Minnesota
PRS Account University of Minnesota
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP