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

NCT ID: NCT04371653

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active group

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

Group Type: EXPERIMENTAL

PRIM-DJ2727

Intervention Type: DRUG

administration orally

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administration orally placebo

Interventions

PRIM-DJ2727

administration orally

Intervention Type: DRUG

Placebo

administration orally placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Herbert DuPont, MD

Professor of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HSC-SPH-19-1126

Identifier Type: -

Identifier Source: org_study_id