# Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)

> **NCT03298048** · PHASE2 · TERMINATED · sponsor: **The University of Texas Health Science Center, Houston** · enrollment: 17 (actual)

## Conditions studied

- Recurrent C. Difficile Infection

## Interventions

- **BIOLOGICAL:** Low fecal microbiota dose
- **BIOLOGICAL:** Mid fecal microbiota dose
- **BIOLOGICAL:** High fecal microbiota dose

## Key facts

- **NCT ID:** NCT03298048
- **Lead sponsor:** The University of Texas Health Science Center, Houston
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2017-12-21
- **Primary completion:** 2019-03-30
- **Final completion:** 2019-06-30
- **Target enrollment:** 17 (ACTUAL)
- **Why stopped:** Investigators are no longer considering FMT product development for C. difficile.
- **Last updated:** 2020-03-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03298048

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03298048, "Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03298048. Licensed CC0.

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