Autologous Fecal Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infectious Disease of Digestive Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Auto fecal microbitoa therapy

autologous fecal microbiota therapy

Group Type EXPERIMENTAL

Autologous fecal microbiota therapy

Intervention Type BIOLOGICAL

Saline enema

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline enema

Interventions

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Autologous fecal microbiota therapy

Intervention Type BIOLOGICAL

Placebo

Saline enema

Intervention Type OTHER

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes