Graft Versus Host Disease in GI TractPhase 3NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

A Phase 3 study testing Fecal microbiota transplantation in people with Graft Versus Host Disease in GI Tract, run by Medical University of Graz at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Graft Versus Host Disease in GI Tract
What is being tested?: Fecal microbiota transplantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteAustria
Study dates: 1 Mar 2017to 31 Dec 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Walter - DDr. Spindelboeck contact

0043 316 385 30195

walter.spindelboeck@medunigraz.at

Austria1 site, 1 recruiting

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
Graz, Styria, 8036
Walter Spindelboeck, DDr., 0043316385 ext. 30195, walter.spindelboeck@medunigraz.at
Walter Spindelboeck, DDr.
Recruiting

Other trials in Austria

About this study

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

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.

Conditions: Graft Versus Host Disease in GI Tract
Being tested: Fecal microbiota transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03819803
Study group	Role	What they receive
Steroid refractory GI-aGvHD	Experimental	Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation Receives: Biological: Fecal microbiota transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

GI-aGvHD remission
Sustained remission of GI-aGvHD (CR or PR)
Measured: 90 days after first FMT

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201731 Dec 2027

First posted29 Jan 2019
Study start1 Mar 2017
Primary completion1 Mar 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Graft Versus Host Disease in GI TractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03819803
Sponsor's protocol ID: GI-aGvHD_01
Status last verified: Nov 2025
First submitted: 14 Sep 2018
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No