UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Acronym	RS study in HSCT
Scientific Title	Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Scientific Title:Acronym	RS study in HSCT
Region	Japan

Condition
Condition	Hematopoietic stem cell transplant recipients
Classification by specialty	Hematology and clinical oncology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether the combination of resistant starch-rich diet and nutritional supplement including oligosaccharides and dietary fibers, can reduce mucositis or gastrointestinal graft-versus-host disease (GVHD) in HSCT recipients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence and duration of severe (grade 3 or more) mucositis
Key secondary outcomes	1) Cumulative incidence of acute GVHD 2) Duration of total parenteral nutrition

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Start RS-rich diet and dietary supplement at the initiation of conditioning regimen, continuing through day +28.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) HSCT recipients. 2) Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria	1) Subjects who are at risk of aspiration. 2) Subjects who are prohibited from eating for any reason. 3) Subject who have an allergy to provided prebiotics. 4) Subjects who are diagnosed with ileus. 5) Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yukiko Middle name Last name Shiraishi
Organization	Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name	Nutrition department
Zip code	113-8677
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL	+81-3-3823-2101
Email	kakihana@cick.jp

Public contact
Name of contact person	1st name Kazuhiko Middle name Last name Kakihana
Organization	Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name	Hematology division
Zip code	113-8677
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL	+81-3-3823-2101
Homepage URL
Email	kakihana@cick.jp

Sponsor
Institute	Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Institute
Department

Funding Source
Organization	Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
Tel	03-3823-2101
Email	rinri@cick.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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 19 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	Main results already published
Date of protocol fixation	2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date	2017 Year 06 Month 19 Day
Last follow-up date	2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 31 Day
Last modified on	2020 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031473