UMIN-CTR Clinical Trial

Basic information
Public title	Effects of formula containing fermented milk products on nutritional status in persons with severe motor and intellectual disabilities (SMID).
Acronym	Effects of formula containing fermented milk products on nutritional status in persons with severe motor and intellectual disabilities (SMID).
Scientific Title	Effects of formula containing fermented milk products on nutritional status in persons with severe motor and intellectual disabilities (SMID).
Scientific Title:Acronym	Effects of formula containing fermented milk products on nutritional status in persons with severe motor and intellectual disabilities (SMID).
Region	Japan

Condition
Condition	Persons with SMID
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of 12 weeks nutritional management by enteral formula containing fermented milk products on the nutritional status in persons with SMID.
Basic objectives2	Others
Basic objectives -Others	Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	There is no primary outcome because this study is exploratory.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12 weeks nutritional management by enteral formula containing fermented milk products.
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) Individuals who provided written informed consent by legally acceptable guardian. *If possible, informed assent will be obtained. 2) Persons with SMID of Oshima classification grade 1-4. 3) Individuals who undergo tube feeding and feces condition is stable (Bristol stool scale: type 3-5).
Key exclusion criteria	1) Individuals who judged inappropriate for the study by the principal. 2) Individuals who refuse informed assent.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Aya Middle name Last name Tokumitsu
Organization	Hokkaido Ryoikuen
Division name	Pediatrics
Zip code	071-8144
Address	4-10, Shunkodai, Asahikawa, Hokkaido, 071-8144, Japan
TEL	0166-51-6524
Email	h-tokumitu@hokuryo.or.jp

Public contact
Name of contact person	1st name Aya Middle name Last name Tokumitsu
Organization	Hokkaido Ryoikuen
Division name	Pediatrics
Zip code	071-8144
Address	4-10, Shunkodai, Asahikawa, Hokkaido, 071-8144, Japan
TEL	0166-51-6524
Homepage URL
Email	h-tokumitu@hokuryo.or.jp

Sponsor
Institute	Hokkaido Ryoikuen
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Meiji Institutional Review Board
Address	Nanakuni, Hachioji, Tokyo, 192-0919, Japan
Tel	042-632-5900
Email	MEIJI.IRB@meiji.com

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	2019 Year 03 Month 01 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	10
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	No longer recruiting
Date of protocol fixation	2018 Year 02 Month 13 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2018 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 19 Day
Last modified on	2019 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035822