UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025800 |
|---|---|
| Receipt number | 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 17:18:19 |
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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
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
shimizh@outlook.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027584
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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