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Recruiting NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

Phase III Interventional Graft Versus Host Disease in GI Tract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota transplantation.
Who it may be relevant to
Registry conditions: Graft Versus Host Disease in GI Tract. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation

Overview

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.

Interventions

  • Biological Fecal microbiota transplantation
    200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum

Primary outcome measures

  • GI-aGvHD remission [Time frame: 90 days after first FMT]
Secondary outcome measures (6)
  • GI-aGvHD remission [Time frame: 45, 180 and 365 days after first FMT]
  • Disease-free survival [Time frame: 180 and 365 days after first FMT]
  • Recurrence of GI-GvHD [Time frame: 365 days after remission]
  • Patient survival [Time frame: 180 and 365 days after first FMT]
  • SUSAR (Suspected Unexpected Serious Adverse Reaction) [Time frame: within 48 hours after a FMT]
  • SAE (Serious Adverse Event) [Time frame: within 48 hours after a FMT]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical Univ — Graz

Identifiers

NCT: NCT03819803 · GI-aGvHD_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗