NCT03359980

Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer

Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: MaaT Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Conditions

• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
DRUG	fecal microbiota transfer	transfer of fecal microbiota from healthy donors to the patients

Timeline

• Start date: 2018-08-13
• Primary completion: 2020-02-25
• Completion: 2020-11-26
• First posted: 2017-12-02
• Last updated: 2021-02-23

Locations

16 sites across 3 countries: France, Italy, Poland