Autologous Fecal Therapy
This trial is active, not recruiting.
|Condition||infectious disease of digestive tract|
|Treatment||autologous fecal microbiota therapy|
|Sponsor||Washington University School of Medicine|
|Start date||March 2014|
|End date||August 2015|
|Trial size||10 participants|
|Trial identifier||NCT02046525, 1U54CK000162, 201312022|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
autologous fecal microbiota therapy
time frame: 90 days after enrollment
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 -
|Official title||Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy|
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