Overview

This trial is active, not recruiting.

Condition infectious disease of digestive tract
Treatment autologous fecal microbiota therapy
Phase phase 2
Sponsor Washington University School of Medicine
Start date March 2014
End date August 2015
Trial size 10 participants
Trial identifier NCT02046525, 1U54CK000162, 201312022

Summary

Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
autologous fecal microbiota therapy
autologous fecal microbiota therapy
(Placebo Comparator)
Saline enema

Primary Outcomes

Measure
microbiome composition
time frame: 90 days after enrollment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: Healthy Adults 18-70 years of age- Exclusion Criteria: history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -

Additional Information

Official title Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.