A prospective clinical study of fecal microbiota transplantation in the treatment of acute intestinal graft-versus-host disease after HSCT

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045163

Enrollment

Unknown

Registered

2021-04-07

Start date

2021-01-01

Completion date

Unknown

Last updated

2021-11-08

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

Conditions

intestinal aGVHD after hematopoietic stem cell transplantation

Interventions

Case series: fecal microbiota transplantation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (ages 18-65 years) who have received allogeneic hematopoietic stem cell transplantation (HSCT) for a variety of blood disorders; 2. Grade III-IV acute graft-versus-host disease (aGVHD) occurred.; 3. Intestinal aGVHD resistant or dependent to steroids; 4. Any type of stem cell source, preconditioning regimen, GVHD prophylaxis, regardless of follow-up treatment with or without donor lymphocyte infusion; 5. Discontinue the use of broad-spectrum antibiotics excreted through digestion at least 12 hours before the implementation of FMT; 6. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Persistent, uncontrolled infection (i.e., bacteremia, hemodynamic instability, persistent fever or bacteremia followed by antibiotic treatment within 3 days); 2. Persistent intestinal diseases other than GVHD, excluding drug-resistant Clostridium difficile infection. 3. The neutrophil count was < 0.5 x 10^9/ L, and the absolute value of platelets was < 10x10^9/ L; 4. X-rays suggest toxic megacolon or gastrointestinal perforation; 5. Active gastrointestinal bleeding; 6. Pregnancy or lactation; 7. Multiple drug resistance exists in fecal detection; 8. Hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba RM, 2007); 9. Late onset aGVHD as defined by the National Institutes of Health (NIH) Consensus Criteria (Jagasia MH, 2015); 10. Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015); 11. The recurrence or progression of malignant tumors requires rapid immunosuppression and withdrawal; 12. Allergic or intolerant to trehalose, maltodextrin or latex 13. Possible clinical contraindications identified by the investigator during the trial..

Design outcomes

Primary

Measure	Time frame
Effective rate;	—

Countries

China

Contacts

Public ContactLi Fei

The First Affiliated Hospital of Nanchang University

yx021021@sina.com+86 13970038386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026