UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027528 |
|---|---|
| Receipt number | R000031241 |
| Scientific Title | The impact of lactobacillus bifidus and soluble dietary fiber on bowel movement and intestinal flora in morbidly obese patients undergoing bariatric surgery |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/29 08:39:42 |
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Basic information
Public title
The impact of lactobacillus bifidus and soluble dietary fiber on bowel movement and intestinal flora in morbidly obese patients undergoing bariatric surgery
Acronym
The impact of lactobacillus bifidus and soluble dietary fiber on bowel movement and intestinal flora in morbidly obese patients undergoing bariatric surgery
Scientific Title
The impact of lactobacillus bifidus and soluble dietary fiber on bowel movement and intestinal flora in morbidly obese patients undergoing bariatric surgery
Scientific Title:Acronym
The impact of lactobacillus bifidus and soluble dietary fiber on bowel movement and intestinal flora in morbidly obese patients undergoing bariatric surgery
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine how supplements containing lactobacillus bifidus and soluble dietary fibers react to bowel movement and intestinal flora before and after bariatric surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of bowel movement and intestinal flora before and 1 month after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1 month ingestion of lactobacillus bifidus containing food.
Interventions/Control_2
1 month ingestion of soluble dietary fiber containing food.
Interventions/Control_3
1 month no ingestion
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Mobid obesity patients undergoing laparoscopic sleeve gastrectomy.
Key exclusion criteria
Patients with diabetes desease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Kikkawa |
Organization
Yotsuya Medical Cube
Division name
Weight Loss and Metabolic Surgery Center
Zip code
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
kikkawa@mcube.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Kikkawa |
Organization
Yotsuya Medical Cube
Division name
Weight Loss and Metabolic Surgery Center
Zip code
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
Homepage URL
kikkawa@mcube.jp
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
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 | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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 | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031241
