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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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-03-06

Study results available
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Summary

To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

Conditions

  • Recurrent C. Difficile Infection

Interventions

BIOLOGICAL

Low fecal microbiota dose

receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days

BIOLOGICAL

Mid fecal microbiota dose

receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment

BIOLOGICAL

High fecal microbiota dose

receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Herbert L DuPont, MD · UTHealth School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2019-03-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298048 on ClinicalTrials.gov