NCT04622475

Efficacy and Safety of FMT Capsule Treating Steroid-refractory GI-aGvHD

Investigator-initiated Trial to Explore the Efficacy and Safety of Fecal Microbiota Transplant (FMT) Capsule in the Treatment of Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD. Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection. The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD. This study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.

Detailed description

This trial is designed to reconstruct the intestinal micro-ecology of patients with steroid-refractory gastrointestinal acute graft versus host disease (GI-aGvHD) by FMT. The primary objective is to evaluate the safety of FMT capsule in the treatment of steroid-refractory GI-aGvHD patients. The secondary objectives are as follows. To observe the efficacy of FMT capsule in the treatment of steroid-refractory GI-aGvHD 28 days after the first administration. To explore the characteristics of gut microbiota changes after FMT capsule treating steroid-refractory GI-aGvHD. To evaluate the safety of FMT capsule treating steroid-refractory GI-aGvHD 12 weeks and 24 weeks after the first administration.

Conditions

• Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant (FMT) Capsule	When enrolled in the study, subjects will ingest 20 FMT capsules/day orally for 3 consecutive days. If the syndrome is not completely recovered or relapse 14 days after the first administration, the subject will receive a booster dose (20 capsules/day for 3 consecutive days).

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-08-01
• Completion: 2022-06-01
• First posted: 2020-11-10
• Last updated: 2020-11-10

Locations

1 site across 1 country: China