Fecal Microbiota Transplantation in aGvHD After ASCT

Medical University of Graz

Status and phase: Enrolling; Phase 3

Conditions: Graft Versus Host Disease in GI Tract

Treatments: Biological: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03819803

GI-aGvHD_01

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Steroid refractory GI-aGvHD

Experimental group

Description:

Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation

Treatment:

Biological: Fecal microbiota transplantation