UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049771 |
|---|---|
| Receipt number | R000056688 |
| Scientific Title | A study to confirm the safety of overdose of bifidobacteria : a placebo-controlled, randomized, double-blind study. |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2023/07/26 11:21:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to confirm the safety of overdose of bifidobacteria : a placebo-controlled, randomized, double-blind study.
Acronym
A study to confirm the safety of overdose of bifidobacteria.
Scientific Title
A study to confirm the safety of overdose of bifidobacteria : a placebo-controlled, randomized, double-blind study.
Scientific Title:Acronym
A study to confirm the safety of overdose of bifidobacteria.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of overdose of bifidobacteria.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Medical interview/Subjective and Objective symptom
2. Body weight (BMI)
3. Blood pressure/Pulse rate
4. Clinical examination
Key secondary outcomes
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
Test food A : Take 5 capsules once daily after dinner for 4 weeks.
Interventions/Control_2
Test food B : Take 5 capsules once daily after dinner for 4 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 with a tendency for constipation (three to five times of defecation per weeks) or with normal defecation (more than 5 times of defecation per weeks).
3. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1. Subjects who regularly take oral medicine (especially laxatives, antiflatulents, laxatives, etc. that affect bowel movements).
2. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment.
3. Subjects who have chronic disease and is under medication.
4. Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (Excluding appendicitis).
5. Subjects who are suffering from other serious diseases.
6. 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 large amounts of sugar alcohol, during the study period.
7. Subjects who are consuming large amounts of alcohol (abouts 40 g or more in terms of pure alcohol) on a daily basis.
8. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history.
9. Subjects who have food and medicine allergy.
10. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
11. 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.
12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
30
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
Clinical Trial Management 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
| 2023 | Year | 09 | Month | 30 | 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
30
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
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056688
