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Low Sulfur Fecal Transplant for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03948919
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Fecal microbiota Other: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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 : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo
Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda Kabage, M.S. 612-624-2956 kabage@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Byron Vaughn    612-301-3981    unger084@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03948919     History of Changes
Other Study ID Numbers: STUDY00005279
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases