Clinical trial NCT04371653: 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
Official title: A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. For sexually active male and female subjects of childbearing potential, agree to use an effective method of birth control during the study.
3. 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.
4. Willing and able to sign an informed consent form and attend study assessments and follow up visits.
5. A documented diagnosis of NAFLD without cirrhosis based on imaging or clinical judgment of a gastroenterologist or hepatologist.
6. History of diabetes mellitus
7. Has an attending physician who will provide non-transplant care for the subject.
8. 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:

1. Unable to take multiple capsules orally.
2. Alcohol consumption of greater than an average of one drink per day for women and two drinks per day for men.
3. Hemochromatosis.
4. Hepatic encephalopathy.
5. 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)
6. Receipt of systemic non-topical antibiotic therapy within 14 days of treatment day 1.
7. History of use of an investigational drug within 90 days prior to the screening visit.
8. Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
9. 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.
10. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
11. Life expectancy of \< 1 year.
12. In the opinion of investigator, subject for any reason, should be excluded from the study.

Primary outcomes:
measure: Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
timeFrame: 10 months
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: 10 months
measure: Number of Participants With an Increase in Flora Diversity in Fecal Samples
timeFrame: 10 months
Secondary outcomes:
measure: Changes in gut motility
timeFrame: 6 months
measure: Monitor subjects' health information
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
References: