At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Autologous fecal microbiota therapy +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy
In Brief
A Phase 2 clinical trial evaluating Autologous fecal microbiota therapy and Placebo for Infectious Disease of Digestive Tract. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfectious Disease of Digestive Tract
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionDec 2018
TodayJul 2026
First PostedJan 27, 2014
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.4 years ago
Interventions
Autologous fecal microbiota therapybiological
Placeboother
Saline enema