UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of synbiotics therapy on microbiome of obesity
Title of the study (Brief title)	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	Hideharu Shimizu
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of Surgery
Address	Musashidai 2-8-29, Fuchu, Tokyo
TEL	042-323-5111
Email	hideharumaki@gmail.com

Public contact
Name of contact person	Itoe Yamamoto
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027584