A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbio… (NCT04371653) | Clinical Trial Compass
WithdrawnPhase 2
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease
Stopped: lack of funds
0Started 2023-12-01
Plain-language summary
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 years of age
✓. For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
✓. For female subjects of childbearing potential, a negative urine Qualitative HCG pregnancy test at enrollment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
✓. Willing and able to sign an informed consent form and attend study assessments and follow up visits.
✓. A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
✓. History of diabetes mellitus
✓. Has an attending physician who will provide non-transplant care for the subject.
✓. Agrees to maintain a stable regimen including weight loss, exercise, medications to control lipids and glucose, and vitamin E therapy if already prescribed, during participation in the study
Exclusion criteria
✕. Unable to take multiple capsules orally.
✕. Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
✕. Hemochromatosis.
✕. Hepatic encephalopathy.
What they're measuring
1
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
Timeframe: 10 months
2
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
Timeframe: 10 months
3
Number of Participants With an Increase in Flora Diversity in Fecal Samples
Timeframe: 10 months
Trial details
NCT IDNCT04371653
SponsorThe University of Texas Health Science Center, Houston
✕. Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent)
✕. Receipt of systemic non-topical antibiotic therapy within 14 days of treatment day 1.
✕. History of use of an investigational drug within 90 days prior to the screening visit.
✕. Positive results for active HIV, Hepatitis B, or Hepatitis C infections.