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

NCT04371653 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HSC-SPH-19-1126
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. .

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus

Outcome Measures

Primary Outcomes (3)

• Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index

  The Shannon diversity index is used to characterize species diversity in a community. Shannon's index accounts for both abundance and evenness of the species present. A high index value would represent a diverse and equally distributed community, and lower values represent a less diverse community. A value of 0 would represent a community with just one species. Typical values are generally between 1.5 and 3.5.

  10 months

• Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

  10 months

• Number of Participants With an Increase in Flora Diversity in Fecal Samples

  10 months

Secondary Outcomes (2)

• Changes in gut motility

  6 months

• Monitor subjects' health information

  10 months

Study Arms (2)

Active group

EXPERIMENTAL

Patients with NAFLD will receive orally fecal microbiota capsules from healthy donors

Drug: PRIM-DJ2727

Placebo group

PLACEBO COMPARATOR

Placebo capsules will be identical to the active capsules, but not contain intestinal bacteria

Drug: Placebo

Interventions

PRIM-DJ2727 DRUG

administration orally

Active group

Placebo DRUG

administration orally placebo

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 1, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05