Fecal microbiota transplantation for steroid-refractory acute GI-GvHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-arm, open-label study evaluating the safety and effectiveness of fecal microbiota transplantation in adults with steroid-refractory acute GI-GvHD after allogeneic stem cell transplantation. Participants receive 250 mL of donor-derived microbiota delivered to the ileum/cecum or duodenum via endoscopy. Outcomes include event-free survival, overall and complete response rates, changes in steroid exposure, adverse events, and biomarker analyses, with 35 participants enrolled over two years. The trial aims to determine whether restoring gut microbiome diversity can improve disease control and survival in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients

   1. Stage II to IV acute GI-GVHD subjects, having \>1000 mL stool per day, diarrhea \> 5 times/day, or abdominal cramping, bleeding or ileus, AND
   2. Resistant to a first-line therapy with corticosteroids (CS)

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   1. Lack of improvement after 5 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose,
   2. Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone or other CS with equivalent dose.
2. Age ≥ 18 years old.
3. Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen.
4. Allow vancomycin-resistant enterococcus (VRE) colonization and asymptomatic cytomegalovirus (CMV) viremia, which is defined as a detectable CMV viral load in plasma but without tissue-invasive disease.
5. Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (antiviral and antifungal agents are allowed)
6. Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship. Subject must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

1. Absolute neutrophil count \< 500 cells/uL.
2. Absolute platelet count \< 30000 /uL which is not correctable by transfusion
3. Hemodynamically unstable status with the following conditions: systolic blood pressure \< 90 mm Hg, pulse oximeter oxygen saturation (SpO2) \< 90%, PaO2 \< 60 mm Hg, or respiratory rate \> 22/minute.
4. Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.

Where it's running

• Chang Gung Memorial Hospital at Linkou
  Taoyuan, Taiwan Recruiting

Study contacts

• Principal investigator: Hsiao-Wen KAO, M.D. — Chang Gung Memorial Hospital
• Study coordinator: Hsiao-Wen Kao, M.D.
• Email: hsiaowen@cgmh.org.tw
• Phone: +886-3-3281200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.