# 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 **NCT04371653** · PHASE2 · WITHDRAWN · sponsor: **The University of Texas Health Science Center, Houston**

## Conditions studied

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

## Interventions

- **DRUG:** PRIM-DJ2727
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04371653
- **Lead sponsor:** The University of Texas Health Science Center, Houston
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2023-12-01
- **Primary completion:** 2024-12-01
- **Final completion:** 2024-12-01
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** lack of funds
- **Last updated:** 2024-05-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04371653

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT04371653. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*