Autologous Fecal Therapy

Phase 2

Completed

• Conditions: Infectious Disease of Digestive Tract
• Interventions: Biological: Autologous fecal microbiota therapy; Other: Placebo

• Registration Number: NCT02046525
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Study Start: 2014-03
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Results First Submitted: 2019-03-25
• Results First Submitted QC: 2019-04-30
• Status Verified: 2019-05
• Results First Posted: 2019-05-22
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Healthy Adults 18-70 years of age-

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auto fecal microbitoa therapy	Autologous fecal microbiota therapy	autologous fecal microbiota therapy
Saline enema	Placebo	Saline enema

Primary Outcome Measures

Name	Time	Method
Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema	90 days after enrollment	Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States