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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025800
Receipt No. R000027584
Scientific Title The effect of synbiotics therapy on microbiome of obesity
Date of disclosure of the study information 2017/01/24
Last modified on 2017/07/25

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Basic information
Public title The effect of synbiotics therapy on microbiome of obesity
Acronym Can synbiotics therapy effectively affect microbiome? (STEAM)
Scientific Title The effect of synbiotics therapy on microbiome of obesity
Scientific Title:Acronym Can synbiotics therapy effectively affect microbiome? (STEAM)
Region
Japan

Condition
Condition Obesity and obesity related diseases
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of synbiotics therapy on body mass index (BMI) and microbiome of obese patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BMI 12 weeks after synbiotics administration
Key secondary outcomes BMI 24 weeks after treatment, fasting blood glucose, lipid, Obesity related diseases, microbiome, adipocytokine, bile acid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 12 weeks administration of Bifidobacterium breve B-3, galacto- and fructo- oligosaccharide, and indigestible dextrin.
Interventions/Control_2 12 weeks administration of maltodextrin, glucose liquid sugar, dextrin
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria BMI25.0-34.9
Outpatients
No significant changes of body weight for 3 months
Key exclusion criteria A patient who has
1. type 2 diabetes, dyslipidemia, or hypertension which starts or changes medication for treatment during last 6 months
2. > 1% Changes of HbA1c during last 3 months
3. history of severe food allergies
4. history of Inflammatory bowel diseases or cancer in the digestive system
5. history of surgery for the digestive system
6. Antibiotics therapy for last 3 months
7. severe psychiatric illness
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideharu Shimizu
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code
Address Musashidai 2-8-29, Fuchu, Tokyo
TEL 042-323-5111
Email hideharumaki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Itoe Yamamoto
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Surgery
Zip code
Address Musashidai 2-8-29, Fuchu, Tokyo
TEL 0423235111
Homepage URL
Email shimizh@outlook.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Government
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
Address
Tel
Email

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 01 Month 24 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 23 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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