Autologous Fecal Therapy

The Washington University

Status and phase: Completed; Phase 2

Conditions: Infectious Disease of Digestive Tract

Treatments: Other: Placebo; Biological: Autologous fecal microbiota therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02046525

1U54CK000162 (U.S. NIH Grant/Contract)

201312022

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Auto fecal microbitoa therapy

Experimental group

Description:

autologous fecal microbiota therapy

Treatment:

Biological: Autologous fecal microbiota therapy

Saline enema

Placebo Comparator group

Description:

Saline enema

Treatment:

Other: Placebo