Skip to content

Clinical Study on Fecal Microbiota Transplantation for Steroid-Resistant Intestinal Acute Graft-Versus-Host Disease After Allo-HSCT

Clinical Study on Fecal Microbiota Transplantation for Steroid-Resistant Intestinal Acute Graft-Versus-Host Disease After Allo-HSCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117498
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant diseases of the blood system

Interventions

Experimental group:Taking oral fecal bacteria capsules for 2 months

Sponsors

923 Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Gastrointestinal Acute Graft-versus-Host Disease (GI-aGVHD): 1.Aged between 18 and 70 years. 2.Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), including peripheral blood stem cell, bone marrow, or cord blood transplantation. 3.Diagnosed with grade II-IV GI-aGVHD according to the NIH consensus criteria. 4.First occurrence of aGVHD. 5.Onset of intestinal aGVHD symptoms occurs between 30 and 100 days post-transplantation. 6.Ability to tolerate oral administration. 7.Signed informed consent form from the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Previous FMT treatment received; 2. Active intestinal infection (such as Clostridioides difficile infection, CMV colitis, etc.); 3. Severe neutropenia (ANC < 0.5×10^9/L); 4. Severe thrombocytopenia (PLT < 20×10^9/L); 5. Severe organ dysfunction (cardiac, hepatic, or renal insufficiency); 6. Recurrence of active malignancy; 7. Pregnant or lactating women; 8. HIV-infected individuals; 9. Allergy to any component in the study protocol; 10. Inability to cooperate with the completion of the study protocol.

Design outcomes

Primary

MeasureTime frame
Objective Remission Rate;

Secondary

MeasureTime frame
Overall Survival;Progression-Free Survival;

Countries

China

Contacts

Public ContactYan Geng

923 Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

drggyn@163.com+86 771 287 0093

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026