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NCT Number: NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

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.

Recruiting

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Key information

Conditions

Graft Versus Host Disease in GI Tract

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz

Graz, Styria, 8036, Austria

Location status: Recruiting

Location contact

Christoph Högenauer, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Peter Neumeister, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Walter Spindelboeck, DDr.

CONTACT

[email protected]

0043316385 ext. 30195

Walter Spindelboeck, DDr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal microbiota transplantation

Biological

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

Primary outcomes

  1. GI-aGvHD remission

    Time frame: 90 days after first FMT

    Sustained remission of GI-aGvHD (CR or PR)

Secondary outcomes

  1. GI-aGvHD remission

    Time frame: 45, 180 and 365 days after first FMT

    Sustained remission of GI-aGvHD (CR or PR)

  2. Disease-free survival

    Time frame: 180 and 365 days after first FMT

    GI-aGvHD free survival

  3. Recurrence of GI-GvHD

    Time frame: 365 days after remission

    Recurrence of GI-GvHD

  4. Patient survival

    Time frame: 180 and 365 days after first FMT

    Survival (death or alive)

  5. SUSAR (Suspected Unexpected Serious Adverse Reaction)

    Time frame: within 48 hours after a FMT

    Number of lethal or non-lethal SUSAR's

  6. SAE (Serious Adverse Event)

    Time frame: within 48 hours after a FMT

    Number of lethal or non-lethal SAE's

Study contacts

Contact information is provided by the study sponsor or research team.

Walter DDr. Spindelboeck

CONTACT

[email protected]

0043 316 385 30195

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2019
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.