Actively Recruiting
Fecal Microbiota Transplantation for the Treatment of Steroid Refractory Acute Gastrointestinal Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Chang Gung Memorial Hospital · Updated on 2026-05-22
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
N
National Taiwan University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a treatment for patients who have severe acute gastrointestinal graft-versus-host disease (GI-GvHD) that does not respond to steroids after receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). This condition occurs when donor immune cells attack the patient's gut, leading to serious health problems and high mortality rates. The study focuses on fecal microbiota transplantation (FMT), which aims to restore a healthy gut microbiome, potentially improving immune balance and patient outcomes. Participants will receive 250 mL of microbiota fluid from healthy donors, delivered directly into the gut either to the terminal ileum or cecum via ileocolonoscopy, or to the duodenum via panendoscopy. After the first FMT, a second dose will be given 7 to 21 days later, with an optional third dose based on how well the patient responds. This is a phase II, single-arm, open-label trial enrolling 35 adults over two years to evaluate safety and effectiveness. During the study, patients will be monitored for event-free survival up to six months, response rates at 28 and 56 days after the first FMT, and overall survival over at least two years. Researchers will also track steroid use, adverse events, and changes in gut microbiology and immune markers. Follow-up assessments will include clinical evaluations and laboratory tests to measure treatment impact and safety throughout the trial period.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage II to IV steroid refractory acute gastrointestinal graft-versus-host disease in allo-HSCT recipients
- Diarrhea more than 5 times per day, stool volume greater than 1000 mL per day, or abdominal cramping, bleeding, or ileus
- Resistance to first-line corticosteroid therapy (lack of improvement after 5 days or progression after 3 days at 2 mg/kg/day methylprednisolone or equivalent)
- Age 18 years or older
- Allo-HSCT with any donor type, stem cell source, prophylaxis, or conditioning regimen
- Allow vancomycin-resistant enterococcus colonization and asymptomatic cytomegalovirus viremia
- Ability to discontinue systemic antibiotics for at least 12 hours before fecal microbiota transplantation
- Signed informed consent by participant or legally acceptable representative
You will not qualify if you...
- Absolute neutrophil count less than 500 cells per microliter
- Absolute platelet count less than 30000 per microliter not correctable by transfusion
- Hemodynamically unstable status (systolic blood pressure less than 90 mm Hg, oxygen saturation less than 90%, PaO2 less than 60 mm Hg, or respiratory rate over 22 per minute)
- Uncontrolled active infection from bacteria, virus, or fungus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks or until the last FMT dose
Participants receive fecal microbiota transplantation (FMT) delivered to the terminal ileum/cecum via ileocolonoscopy or to the duodenum via panendoscopy. A second FMT is given 7 to 21 days later, with an optional third dose based on response.
2 to 3 visits (in-person)
Duration - Up to 2 years
Participants are monitored for event-free survival, response rates, adverse events, and survival outcomes for up to 6 months, with some outcomes assessed up to two years after the first FMT.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan, 333423
Actively Recruiting
Research Team
H
Hsiao-Wen Kao, M.D.
T
Tung-Lian Lin, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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