Status:
WITHDRAWN
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
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 rece...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
- Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
- History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
- Life expectancy of \< 1 year.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04371653
Start Date
December 1 2023
End Date
December 1 2024
Last Update
May 14 2024
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