Trial record 41 of 2007 for:    digestive | Open Studies | Exclude Unknown | United States

Autologous Fecal Therapy

This study is not yet open for participant recruitment.
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02046525
First received: January 23, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infectious Disease of Digestive Tract
Biological: Autologous fecal microbiota therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • microbiome composition [ Time Frame: 90 days after enrollment ] [ Designated as safety issue: No ]
    microbial community composition (taxa that are present) and structure (abundance of taxa)


Estimated Enrollment: 10
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auto fecal microbitoa therapy
autologous fecal microbiota therapy
Biological: Autologous fecal microbiota therapy
Placebo Comparator: Saline enema
Saline enema

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02046525

Locations
United States, Missouri
Washington University in St. Louis Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Kerry Bommarito, PhD    314-454-8221    kbommarito@wustl.edu   
Principal Investigator: Erik Dubberke, MD         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02046525     History of Changes
Other Study ID Numbers: 201312022, 1U54CK000162
Study First Received: January 23, 2014
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Fecal microbiota therapy

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on April 14, 2014