Phase 2 N=10 Randomized Single-blind Prevention

Autologous Fecal Therapy

Infectious Disease of Digestive Tract

Bottom Line

View on ClinicalTrials.gov: NCT02046525 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema — 5; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Autologous fecal microbiota therapy (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema	5; 5	—

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.

Eligibility Criteria

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 -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02046525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.