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Autologous Fecal Therapy

Primary Purpose

Infectious Disease of Digestive Tract

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous fecal microbiota therapy
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease of Digestive Tract focused on measuring Fecal microbiota therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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 -

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Auto fecal microbitoa therapy

Saline enema

Arm Description

autologous fecal microbiota therapy

Saline enema

Outcomes

Primary Outcome Measures

Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema
Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2014
Last Updated
May 24, 2019
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02046525
Brief Title
Autologous Fecal Therapy
Official Title
Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease of Digestive Tract
Keywords
Fecal microbiota therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auto fecal microbitoa therapy
Arm Type
Experimental
Arm Description
autologous fecal microbiota therapy
Arm Title
Saline enema
Arm Type
Placebo Comparator
Arm Description
Saline enema
Intervention Type
Biological
Intervention Name(s)
Autologous fecal microbiota therapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline enema
Primary Outcome Measure Information:
Title
Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema
Description
Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.
Time Frame
90 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30463925
Citation
Bulow C, Langdon A, Hink T, Wallace M, Reske KA, Patel S, Sun X, Seiler S, Jones S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Impact of Amoxicillin-Clavulanate followed by Autologous Fecal Microbiota Transplantation on Fecal Microbiome Structure and Metabolic Potential. mSphere. 2018 Nov 21;3(6):e00588-18. doi: 10.1128/mSphereDirect.00588-18.
Results Reference
derived

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Autologous Fecal Therapy

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