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

Acute Graft Versus Host Disease in Intestine Clinical Trial

Official title:

Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711967
• Other study ID #: 2020SDUCRCC015
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Qilu Hospital of Shandong University
• Contact: Shuqian Xu
• Phone: +86 0531-88382169
• Email: shuqian.xu[@]email.sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease in Intestine
• Graft vs Host Disease

Intervention

Biological:
• Fecal Microbiota Transplantation
fecal microbiota transplantation

Drug:
• drug
drug

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing
China	Shandong university qilu hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in times of stool	Change in times of stool per day within 28 days after FMT	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Primary	change in volume of stool	Change in volume of stool per day within 28 days after FMT	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Secondary	Change in life quality up to 28 days	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	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.