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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT03948919 |
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Date of registration:
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10/05/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Low Sulfur Fecal Transplant for Ulcerative Colitis
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Scientific title:
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Low Sulfur Fecal Transplant for Ulcerative Colitis |
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Date of first enrolment:
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July 31, 2019 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03948919 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Byron Vaughn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
89 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Fecal microbiota
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Other: Placebo
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Primary Outcome(s)
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Engraftment of low sulfate reducing microbiota
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Clinical efficacy of FMT versus placebo
[Time Frame: 8 weeks]
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Clinical efficacy of low sulfate reducing microbiota
[Time Frame: 12 weeks]
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Rate of change of sulfate reducing microbiota
[Time Frame: 4 weeks]
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Serious adverse events
[Time Frame: 12 weeks]
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Secondary ID(s)
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GI-2019-27285
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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