Fecal Microbiota Transplantation in aGvHD After ASCT

Phase 3

Recruiting

• Conditions: Graft Versus Host Disease in GI Tract

• Registration Number: NCT03819803
• Lead Sponsor: Medical University of Graz

Brief Summary

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.

Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.

Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-03-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• first episode of histologically confirmed, steroid-refractory GI-aGvHD
• reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
• eligibility for repeated colonoscopic procedures
• informed consent

Exclusion Criteria

• complications during a previous colonoscopy
• recurrent episode of GI-aGvHD
• lacking cardiopulmonary fitness for repeated colonoscopic procedures
• septic infection
• acute extraintestinal organ failure (excluding bone marrow)
• mechanical ileus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
GI-aGvHD remission	90 days after first FMT	Sustained remission of GI-aGvHD (CR or PR)

Secondary Outcome Measures

Name	Time	Method
GI-aGvHD remission	45, 180 and 365 days after first FMT	Sustained remission of GI-aGvHD (CR or PR)
Recurrence of GI-GvHD	365 days after remission	Recurrence of GI-GvHD
SAE (Serious Adverse Event)	within 48 hours after a FMT	Number of lethal or non-lethal SAE's
SUSAR (Suspected Unexpected Serious Adverse Reaction)	within 48 hours after a FMT	Number of lethal or non-lethal SUSAR's
Patient survival	180 and 365 days after first FMT	Survival (death or alive)
Disease-free survival	180 and 365 days after first FMT	GI-aGvHD free survival

Trial Locations

Locations (1)

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz; 🇦🇹 Graz, Styria, Austria