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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.