Intestinal Microbiome-based Research for the Prevention of Acute GVHD

Intestinal Microbiome-based Research for the Prevention of Acute Graft-versus-host Disease

Hematopoietic stem cell transplantation consists of preconditioning chemotherapy, stem cell infusion, and engraftment of hematopoietic stem cells. In this process, in the case of recipients who receive hematopoietic stem cells, their immune system is completely destroyed and then undergoes a situation in which it is reconstituted. In this process, the diversity of the intestinal microbiome is reduced, and it is widely known that a severe decrease is associated with the occurrence of an acute graft-versus-host reaction. Attempts to improve the intestinal microbiome include prebiotics, probiotics, and postbiotics. Prebiotics can be expected to improve the intestinal microbiome by acting as nutrients for beneficial bacteria in the intestine, but their role may be limited in situations where the diversity of the intestinal microbiome has already decreased. Probiotics are a method to expect improvement of the intestinal microbiome by administering the beneficial bacteria themselves in the intestine, but there is a difficulty in reaching the intestine properly through stomach acid, and there is a risk of causing sepsis in immunocompromised patients. Postbiotics is a product that beneficial bacteria metabolize and release prebiotics in the intestine, and the microbiome in the intestine is actually responsible for the function that affects the human body. Therefore, in this study, postbiotics are administered to patients undergoing hematopoietic stem cell transplantation who are concerned that the diversity of the intestinal microbiome may have already decreased, to improve the intestinal microbiome and hope to prevent graft-versus-host reactions through this. Furthermore, it is intended to improve the outcome of allogeneic hematopoietic stem cell transplantation.

Study Overview

• Status: Recruiting
• Conditions: Graft Versus Host Disease; Postbiotics; Butyrate
• Intervention / Treatment: Drug: sodium butyrate

Detailed Description

1. step After explaining the background and purpose of the study to the subjects undergoing hematopoietic stem cell transplantation at Soonchunhyang University Seoul Hospital and obtaining consent, before transplantation (D-7), on the day of transplantation (D0), and at the time of engraftment after transplantation (D+ 14), 30 days after transplantation (D+30), 3 months after transplantation (D+90), if complications occur after a total of 5 times, if the researcher deems it necessary, with the consent of the patient, additional feces are collected. About 10g per dose will be received and stored in a freezer at the Institute of Clinical Molecular Biology, Soonchunhyang University until December 2027, and DNA will be extracted and microbiome analyzed later, and discarded at the end of the study. In the process of allogeneic hematopoietic stem cell transplantation, the subjects had difficulty in oral intake during the transplantation process after pretreatment chemotherapy, so at the time of engraftment oral intake was possible, starting to take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭) for 3 months after transplantation Continue taking until All expenses incurred in the course of testing are borne by the researcher. The patient's clinical progress and test results related to hematopoietic stem cell transplantation are investigated based on medical records.
2. Duration of subject participation and expected number of subjects For patients undergoing hematopoietic stem cell transplantation at our hospital from the date of IRB approval to December 2023 (About 20 patients a year receive hematopoietic stem cell transplantation at our center, and it is expected that about 30 patients will participate)
3. Clinical Study Restrictions and Subject Obligations Subjects who agreed to the study must take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭) from the time of engraftment to 3 months after transplantation, and must collect and submit feces at the designated time and in an appropriate way.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seug Yun Yoon, MD; Phone Number: +82 010-9267-2281; Email: ysy6496@schmc.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04401
    • Recruiting
    • Soonchunhyang University Seoul Hospital
    • Contact: Seug Yun Yoon, MD; Phone Number: +82 010-9267-2281; Email: ysy6496@schmc.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing hematopoietic stem cell transplantation
• Adult patients over 19 years and under 70 of age

Exclusion Criteria:

• Patients who did not agree to participate in the study
• If feces are not suitable for analysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butyrate; Take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭ per day)	Drug: sodium butyrate; Take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭, per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of GVHD	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Study Chair: Jong-Ho Won, MD, PhD, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Graft Versus Host Disease; butyrate; postbiotics
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Butyric Acid
• Other Study ID Numbers: 2022-06-011

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