UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031370
Receipt No. R000035822
Scientific Title Effects of formula containing fermented milk products on nutritional status in persons with severe motor and intellectual disabilities (SMID).
Date of disclosure of the study information 2019/03/01
Last modified on 2019/08/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000035822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.