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

NCT03359980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-23

No results posted yet for this study

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

DRUG

fecal microbiota transfer

transfer of fecal microbiota from healthy donors to the patients

Sponsors & Collaborators

  • MaaT Pharma

    lead INDUSTRY

Principal Investigators

  • Florent Malard, MD, PhD · Hôpital Saint Antoine - PARIS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2020-02-25
Completion
2020-11-26

Countries

  • France
  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359980 on ClinicalTrials.gov