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.
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
- Are there results?
- Not yet: the study is under way
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.
Austria1 site, 1 recruiting
- 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.
About this study
Official title: Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
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.
- 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 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.
- 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.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Prof. Dr. Neumeister, Principal investigator, Department of Internal Medicine, Division of Hematology, Medical University of Graz
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03819803
- Acronym / sponsor ID
- GI-aGvHD_01
- Conditions
- Graft Versus Host Disease in GI Tract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
| Arm | Type | Receives |
|---|---|---|
| Steroid refractory GI-aGvHD | Experimental | Biological: Fecal microbiota transplantationPatients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum | Biological | Steroid refractory GI-aGvHD |
Primary outcome
GI-aGvHD remission
Time frame: 90 days after first FMT
Sustained remission of GI-aGvHD (CR or PR)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Prof. Dr. Neumeister principal investigator
Department of Internal Medicine, Division of Hematology, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter - DDr. Spindelboeck (0043 316 385 30195, walter.spindelboeck@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI-aGvHD remission (time frame: 90 days after first FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.