UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053634 |
|---|---|
| Receipt number | R000061215 |
| Scientific Title | Study on the confirmatory effects of lactic acid bacteria for intestinal regulation. -A randomized, placebo-controlled, double-blind, parallel-group comparison study - |
| Date of disclosure of the study information | 2024/03/02 |
| Last modified on | 2024/02/16 17:54:49 |
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Basic information
Public title
Study on the confirmatory effects of lactic acid bacteria for intestinal regulation.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study -
Acronym
Study on the confirmatory effects of lactic acid bacteria for intestinal regulation.
Scientific Title
Study on the confirmatory effects of lactic acid bacteria for intestinal regulation.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study -
Scientific Title:Acronym
Study on the confirmatory effects of lactic acid bacteria for intestinal regulation.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the regulatory effects of lactic acid bacteria on individuals with a tendency toward constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
(1) Frequency of bowel movements, stool volume, stool consistency, color, odor, and post-defecation sensation.
(2) Metagenomic analysis using next-generation sequencing.
3) Ammonia Concentration in Stool.
4) Fecal Putrefaction Products (Indole, p-Cresol, Skatole, Phenol, 4-Ethylphenol).
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
Consume test food once a day for 4 weeks.
Interventions/Control_2
Consume placebo food once a 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 20 and over but under 65, who have bowel movements 3 to 5 times per week.
2) Subjects whose Bifidobacterium count in the feces collected at screening was low and the proportion relative to the total bacterial count was also low.
3) Subjects who usually eat 3 meals regularly.
4) Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Key exclusion criteria
Subjects who
1)are suffering from or have a history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease.
2)regularly use laxatives and probiotics.
3)cannot stop consuming health foods believed to improve constipation during the study period.
4)cannot stop consuming probiotic-containing foods such as lactic acid bacteria, bifidobacteria, and Bacillus natto, prohibited foods fortified with oligosaccharides and dietary fiber, specified health foods that are thought to improve constipation, foods with functional claims, and foods with high sugar alcohol concentrations during the study period.
5)have been regularly consuming foods containing lactobacilli, bifidobacteria, and oligosaccharides for the purpose of alleviating constipation.
6)have taken antibiotics within the past 2 weeks during the screening test or control food intake period.
7)have a history of digestive diseases or surgical procedures affecting digestion and defecation.
8)been diagnosed with Irritable Bowel Syndrome or Inflammatory Bowel Disease.
9)have self-reported allergies to ingredients in the study food materials.
10)cannot stop drinking from 2 days before each measurement.
11)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 5 days a week.
12)are shiftworker or midnight-shift worker.
13)are pregnant or wish to become pregnant during the study period or are breastfeeding.
14)have donated blood or blood components exceeding 200 mL within one month prior to the consent date or 400 mL within three months prior to the consent date.
15)plan to participate in other clinical study during study periods or had participated in other clinical study within the last 1 month.
16)are judged by the principal investigator to be inappropriate as study subjects for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.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
Nichinichi pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Gunma
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
| 2024 | Year | 03 | Month | 02 | 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
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061215
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
