UMIN-CTR Clinical Trial

Basic information
Public title	Impact of gut environment on the development of intestinal graft-versus-host disease, a complication of hematopoietic stem cell transplantation
Acronym	Impact of gut environment on the development of intestinal graft-versus-host disease, a complication of hematopoietic stem cell transplantation
Scientific Title	Impact of gut environment on the development of intestinal graft-versus-host disease during allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym	Impact of gut environment on the development of intestinal graft-versus-host disease during allogeneic hematopoietic stem cell transplantation
Region	Japan

Condition
Condition	Hematological disorders eligible for allogeneic hematopoietic stem cell transplantation
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the gut environment involved in the pathogenesis of intestinal GVHD and to identify predictive markers and novel targets that contribute to the modulation of intestinal GVHD pathogenesis.
Basic objectives2	Others
Basic objectives -Others	Unraveling disease pathophysiology
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Gut environment involved in the onset of intestinal GVHD
Key secondary outcomes	The gut environment involved in the severity of intestinal GVHD Intestinal environment involved in prognosis after transplantation Similarity of gut environment between patients and donors and its relation to pathogenesis and prognosis of GVHD Alterations in the gut environment during the process from autologous to donor hematopoiesis Comparison of the gut environment in intestinal GVHD and inflammatory bowel disease Relationship between endoscopic findings and severity of intestinal GVHD

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients and their donors undergoing allogeneic hematopoietic stem cell transplantation at Yamagata University Hospital Patients and their donors who have been fully informed of the purpose of the study in the consent document approved by the Ethical Review Committee and have given their free written consent. Patients and their donors who are 20 years of age or older at the time of consent.
Key exclusion criteria	Patients with synchronous multiple cancers. Patients with a history of bowel resection. Patients who are unable to collect stool. However, if only the donor is unable to collect stool and the patient is able to collect stool, the patient will not be excluded. Other patients deemed inappropriate by the investigators.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Ueno
Organization	Faculty of Medicine, Yamagata University
Division name	Department of Gastroenterology
Zip code	990-9585
Address	2-2-2 Iida-Nishi, Yamagata, Japan
TEL	0236285309
Email	y-ueno@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Sasaki
Organization	Faculty of Medicine, Yamagata University
Division name	Department of Gastroenterology
Zip code	9909585
Address	2-2-2 Iida-Nishi, Yamagata, Japan
TEL	0236285309
Homepage URL
Email	y-sasaki@med.id.yamagata-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Yamagata University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Support Division, Administrative Department, Yamagata University Iida Campus
Address	2-2-2 Iida-Nishi, Yamagata, Japan
Tel	023-628-5047
Email	ikekenkyu@jm.kj.yamagata-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	山形大学医学部附属病院/Yamagata University Hospital

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 02 Month 19 Day
Date of IRB	2021 Year 04 Month 20 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Prospective observational study The patients and their donors aged 20 years or older who will undergo allogeneic hematopoietic stem cell transplantation at Yamagata University Hospital between May 1, 2021 and March 31, 2026. Any indication that led to the transplant is eligible. The clinical, hematological, and endoscopic findings, gut microbiota, and gut metabolome will be compared between the GVHD group and the non-GVHD group before transplantation and throughout the period of donor-derived hematopoietic engraftment. We will also compare the gut environments of donors and recipients.

Management information
Registered date	2021 Year 04 Month 23 Day
Last modified on	2021 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050266