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NCT Number: NCT02133651

Mucosal Versus Fecal Microbiota in FMT

Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea. Treatment of this infection usually occurs using other antibiotics, but many individuals have persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota Transplantation, (IMT) has been shown to be efficacious when administered after treatment for C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via colonoscopy, and determine if there are differences in the mucosal flora as compared to the stool flora. The investigators hope to discover the critical parts of a healthy microbiota.

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Key information

Conditions

Clostridium Difficile Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital

Atlanta, Georgia, 30324, United States

About this study

A total of 20 subjects with at least one relapse of Clostridium difficile infection undergoing Intestinal Microbiota Transplantation via colonoscopy will be recruited in this study. The patients will produce a stool specimen at the time of colonoscopy and a biopsy will be obtained during the colonoscopy. At 2 weeks and 10 weeks, stool specimens and anoscopy will be collected to be tested for C. difficile polymerase chain reaction (PCR) and the fecal microbiota. Subjects will be referred from all locations of Emory Healthcare.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient or outpatient adults, age ≥18
  • Have had at least 1 relapse of C. difficile
  • Patients who have had previous FMT

Exclusion criteria

  • Pregnant or breastfeeding
  • Critically or acutely ill (Fever will be defined as a documented temperature >37.8°C)
  • Ileus or toxic megacolon
  • Unable to give consent

Treatment and study plan

Primary outcomes

  1. The proportion of subjects who experience resolution of diarrhea associated with C. difficile infection without relapse 2 weeks and 10 weeks post Intestinal Microbiota Transplantation (IMT)

    Time frame: 10 weeks post IMT

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Characterization of the Microbial Genomics of Fecal Bacteriotherapy (FBT): Intestinal Microbiota Transplantation (IMT) for Recurring Clostridium Difficile

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 8, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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