NCT02733744

Fecal Microbiota Transplantation After HSCT

A Pilot Study to Determine the Feasibility of Fecal MicrobiotaTransplantation (FMT) in Hematopoietic Stem Cell Transplantation (HSCT) Recipients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying an intervention called fecal microbiota transplantation (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic engraftment. The primary endpoint will be to assess the feasibility of FMT in this population and to assess safety.

Detailed description

The microbiome (spectrum of bacteria in a patient's gut) is thought to play a role in helping to shape one's immune system given its direct contact with normal cells in our intestine. Recent studies have suggested that a microbiome with very few bacteria (low diversity) seems to be bad for health and a high-diversity microbiome (many different species) appears to be good. This appears to be true even for patients after HSCT where low diversity microbiome status has correlated with infections, GVHD and overall survival. Fecal microbiota transplantation (FMT) is routinely performed for an infection caused by Clostridium difficile but is not yet approved by the FDA as a treatment for any disease. FMT restores a high diversity microbiome. It is hoped that through FMT, overall outcomes after HSCT can potentially be improved. FMT will be performed in the first 3 weeks after recovery of white blood cells after HSCT. The source of FMT will be from healthy 3rd party donors. FMT will be performed through the ingestion of 30 capsules over 2 consecutive days.

Conditions

• Bone Marrow Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation (FMT)	FMT will be given through the ingestion of 30 capsules (15 capsules daily x 2 consecutive days)

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2016-04-11
• Last updated: 2017-12-22

Locations

1 site across 1 country: United States