UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045353 |
|---|---|
| Receipt number | R000051713 |
| Scientific Title | Effect of Bifidobacteria on defecation in healthy volunteers : a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2022/09/29 10:30:32 |
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Basic information
Public title
Effect of Bifidobacteria on defecation in healthy volunteers : a randomized, double-blind, placebo-controlled trial.
Acronym
Effect of Bifidobacteria on defecation in healthy volunteers
Scientific Title
Effect of Bifidobacteria on defecation in healthy volunteers : a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
Effect of Bifidobacteria on defecation in healthy volunteers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intervention with Bifidobacteria to defecation in healthy subjects with constipation tendency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
1. Defecation days
2. Fecal amount
3. Stool consistency (Bristol stool scale)
4. Straining during defecation
5. Pain during defecation
6. Feeling of incomplete evacuation after defecation
7. Abdominal bloating
8. Fecal water content
9. QOL questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take test food A once a day, 1 capsule, for 2 weeks.
Interventions/Control_2
Take test food B once a day, 1 capsule, for 2 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Males and females from 20 to 64 years of age.
2.Subjects who usually have two or more meals a day.
3.Subjects with constipation tendency at three to five times of defecation per weeks.
4.Subjects with a tendency for hard stool.
5.Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1.Subjects who fall in more than over a quarter to Bristol stool scale 1 or 2.
2.Subjects who are taking medicine.
3.Subjects who are taking health foods which are said to improve constipation at the point of screening examination.
4.Subjects who are having been taken antibacterial drug within 2 weeks at the point of before screening examination.
5.Subjects who are not able to stop ingesting foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods that are said to be good for improving constipation, foods containing a large amount of sugar alcohol, and/or taking antibacterial drugs, laxatives, intestinal regulators, constipation drugs during the study period.
6.Subjects who are consuming large amounts of alcohol on a daily basis.
7.Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation.
8.Subjects with chronic illness who regularly use medicine (including IBS and IBD)
9.Subjects who have food and medicine allergy.
10.Subjects who are affected from or under treatment of serious disease.
11.Subjects who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire.
12.Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
13.Subjects who participate in other clinical trials ,who have participated in other tests within one month of obtaining consent, or who are willing to participate.
14.Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sagami |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70 Konan Minato ku Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Biofermin Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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 | 29 | 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
120
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 | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051713
