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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Graft Versus Host Disease in Intestine
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation; Drug: drug

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuqian Xu; Phone Number: +86 0531-88382169; Email: shuqian.xu@email.sdu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Meng p Lv; Phone Number: 13701140918
  • Shandong
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Shandong University Qilu Hospital
      • Contact: Shuqian Xu, Ph. D, M. D.; Phone Number: 18560087013; Email: shuqian.xu@email.sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Peking University People's Hospital
• Investigators: Principal Investigator: Shuqian Xu, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Fecal microbiota transplantation; Acute-graft-versus-host Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 2020SDUCRCC015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No