Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Not Applicable

• Conditions: Acute Graft Versus Host Disease in Intestine
• Interventions: Biological: Fecal Microbiota Transplantation; Drug: drug

• Registration Number: NCT04711967
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.

Detailed Description

Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

Study Timeline

• Study First Submitted: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-03-10
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. received allo-HSCT due to a hematopoietic disease
2. corticosteroid resistant/dependent intestinal GVHD
3. ECOG≤2
4. Sign informed Consent
5. No major organ dysfunction

Exclusion Criteria

1. uncontrolled or severe infections
2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
3. high-risk bleeding
4. ANC<0.5×10^9/L or PLT<20x10^9/L
5. hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
6. patients participating in other clinical trials
7. patienta who suffer from mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation group	Fecal Microbiota Transplantation	treat with FMT
Control group	drug	treat with traditional medicine

Primary Outcome Measures

Name	Time	Method
change in volume of stool	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	Change in volume of stool per day within 28 days after FMT
change in times of stool	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	Change in times of stool per day within 28 days after FMT

Secondary Outcome Measures

Name	Time	Method
Change in life quality up to 28 days	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	The change quality of patients life within 28 days after FMT is assessed by "EORTC Quality of Life measurement Scale QLQ-C30 (V3.0)" with a score ranged 0\~100. And the higher the score, the better the functional status and quality of life

Trial Locations

Locations (2)

Shandong university qilu hospital; 🇨🇳 Jinan, Shandong, China

Peking university people's hospital; 🇨🇳 Beijing, Beijing, China