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

• Sponsor: Qilu Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04711967
• Collaborator: Peking University People's Hospital (Other)
• Enrollment: 20
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 33.7
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Graft Versus Host Disease in Intestine	Biological: Fecal Microbiota Transplantation; Drug: drug	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: Mar 10, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fecal Microbiota Transplantation group treat with FMT	Biological: Fecal Microbiota Transplantation; fecal microbiota transplantation
Active Comparator: Control group treat with traditional medicine	Drug: drug; drug

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking university people's hospital	Beijing	Beijing	China	100044
2	Shandong university qilu hospital	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Qilu Hospital of Shandong University
• Peking University People's Hospital

Investigators

• Principal Investigator: Shuqian Xu, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT04711967
• Other Study ID Numbers: 2020SDUCRCC015
• First Posted: Jan 15, 2021
• Last Update Posted: Aug 31, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qilu Hospital of Shandong University: Acute-graft-versus-host Disease; Fecal microbiota transplantation
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Aug 31, 2021