UMIN-CTR Clinical Trial

Basic information
Public title	Metagenome analysis of microbiota in patients with severe motor and intellectual disabilities and intervention of bifidobacterium
Acronym	Intervention of bifidobacterium in SMIDs
Scientific Title	Metagenome analysis of microbiota in patients with severe motor and intellectual disabilities and intervention of bifidobacterium
Scientific Title:Acronym	Intervention of bifidobacterium in SMIDs
Region	Japan

Condition
Condition	Severe motor and intellectual disabilities
Classification by specialty	Gastroenterology Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We examined microbiota in patients with severe motor intellectual disabilities and intervention of bifidobacterium
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metagenome analysis of microbiota before and after 4 weeks and 8 weeks during treatment, and after 4 weeks of cessation
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	intervention period: 8 weeks dosage: bifidobacterium BB536 2g/day intervention: once a day
Interventions/Control_2	intervention period: 8 weeks dosage: lactulose 10g/day intervention: once a day
Interventions/Control_3	intervention period: 8 weeks dosage: bifidobacterium BB536 2g/day+lactulose 10g/day intervention: once a day
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)patients with severe motor and intellectual disabilities 2)tube feeding
Key exclusion criteria	usage of anti-biotics
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name Tanuma
Organization	Tokyo Metropolitan Fuchu Medical Center for the Disabled
Division name	Department of Pediatrics
Zip code	183-8553
Address	2-9-2, Musashidai, Fuchu, Tokyo 183-8553
TEL	042-323-5115
Email	Naoyuki_Tanuma@member.metro.tokyo.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Tanuma
Organization	Tokyo Metropolitan Fuchu Medical Center for the Disabled
Division name	Department of Pediatrics
Zip code	183-8553
Address	2-9-2, Musashidai, Fuchu, Tokyo 183-8553
TEL	042-323-5115
Homepage URL
Email	Naoyuki_Tanuma@member.metro.tokyo.jp

Sponsor
Institute	Tokyo Metropolitan Fuchu Medical Center for the Disabled
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Metropolitan Fuchu Medical Center for the Disabled
Address	2-9-2, Musashidai, Fuchu, Tokyo 183-8553
Tel	042-323-5115
Email	Naoyuki_Tanuma@member.metro.tokyo.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	2022 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	39
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	Completed
Date of protocol fixation	2021 Year 04 Month 01 Day
Date of IRB	2020 Year 07 Month 27 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 25 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055554