Phase 2 Completed N=10 Randomized Single-blind Prevention

Autologous Fecal Therapy

Infectious Disease of Digestive Tract

Source: ClinicalTrials.gov NCT02046525 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcomePrimary: 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

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.

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	—

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 -

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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. Informational only — not medical advice.