UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048911 |
|---|---|
| Receipt number | R000055732 |
| Scientific Title | A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.-A randomized, double-blind,placebo-controlled, parallel-group comparative study - |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2024/08/29 10:35:02 |
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Basic information
Public title
A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.-A randomized, double-blind,placebo-controlled, parallel-group comparative study -
Acronym
A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.
Scientific Title
A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.-A randomized, double-blind,placebo-controlled, parallel-group comparative study -
Scientific Title:Acronym
A clinical study for evaluating the effects of food containing lactic acid bacteria on defecation.
Region
| Japan |
Condition
Condition
Subjects with a tendency for constipation
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of food containing lactic acid bacteria for 4 weeks on defecation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of defecation per week.
Key secondary outcomes
Defecation survey, number of Lactobacilli in feces, number of Bifidobacteria and C. perfringens in feces, analysis of gut microbiota, organic acids content in feces, bile acids content in feces, putrefactive products content in feces, ammonia content in feces, fecal pH, water content in feces, gastrointestinal feelings, and JPAC-QOL.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingest the capsules containing the target lactic acid bacteria every day for 4 weeks.
Interventions/Control_2
Ingest the capsules without the target lactic acid bacteria every day 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 20 to 64 years.
2) Subjects with 3 to 5 defecation per week.
3) Subjects who can visit the testing institution.
4) Subjects who fully understand the purpose and content of the study and agree in writing prior to the start of the study.
Key exclusion criteria
1) Subjects taking medicines/foods that affect the intestinal environment at least 3 times a week.
2) Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease.
3) Subjects with chronic diseases and regular users of medicines.
4) Subjects with a history or current history of drug or alcohol dependence
5) Subjects with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation.
6) Subjects with food allergies related to the test food.
7) Subjects with extremely irregular daily habits and eating habits (including late-night workers).
8) Subjects who regularly use medicines or foods that affect the study.
9) Subjects who cannot restrict the use of drugs/foods that affect the study after obtaining consent.
10) Subjects with excessive habits of exercise, drinking and smoking.
11) Pregnant or lactating women or women who may become pregnant during the study period.
12) Subjects who have taken or will take antibiotics within 1 month prior to obtaining consent during the study period.
13) Participated, are currently participating, or will participate during the study period, in any other clinical research within 1 month prior to obtaining consent.
14) Subjects who plan to change their lifestyle drastically after obtaining consent and before the end of the study.
15) Subjects who plan to travel abroad after obtaining consent and before the end of the study.
16) Subjects judged to be unsuitable based on their answers to the background questionnaire.
17) Other subjects who are judged by the investigator to be unsuitable for the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Tomita |
Organization
New drug research center, Inc.
Division name
Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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 Fukuzumi internal medicin Clinic
Address
5F,2-1-2-5,Fukuzumi,Toyohira,Sapporo,Hokkaido
Tel
011-836-3531
s-fukui@jikokai.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 | 12 | Month | 04 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | 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 | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055732
