Intestinal Microbiome-based Research for the Prevention of Acute GVHD

NCT05808985 | Unknown Phase 2

• 1 other identifier: 2022-06-011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease; Postbiotics; Butyrate

Keywords

butyrate; Graft Versus Host Disease; postbiotics

Outcome Measures

Primary Outcomes (1)

• Incidence of GVHD

  through study completion, an average of 1 year

Study Arms (1)

Butyrate

EXPERIMENTAL

Take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭ per day)

Drug: sodium butyrate

Interventions

sodium butyrate DRUG

Take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭, per day)

Butyrate

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Seoul Hospital

Seoul, 04401, South Korea

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Jong-Ho Won, MD, PhD

  Soonchunhyang University Hospital

  STUDY CHAIR

Central Study Contacts

Seug Yun Yoon, MD

CONTACT

+82 010-9267-2281; ysy6496@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Take butyric acid (sodium butylate 600mg 2 tablets, BodyBio⒭)

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: April 12, 2023
• Study Start: September 2, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)