UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027563
Receipt number R000031473
Scientific Title Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Date of disclosure of the study information 2017/06/19
Last modified on 2020/04/15 16:27:33

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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 or person

Institute

Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031473


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name