UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037731 |
|---|---|
| Receipt number | R000043036 |
| Scientific Title | Investigation of relationship between defecation frequency and intestinal environment in infants |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2023/06/30 10:59:41 |
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Basic information
Public title
Investigation of relationship between defecation frequency and intestinal environment in infants
Acronym
Investigation of relationship between defecation frequency and intestinal environment in infants
Scientific Title
Investigation of relationship between defecation frequency and intestinal environment in infants
Scientific Title:Acronym
Investigation of relationship between defecation frequency and intestinal environment in infants
Region
| Japan |
Condition
Condition
Male and Female
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of relationship between defecation frequency and gut environment
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between defecation frequency and factors in intestinal environment data based on microbiota analysis and metabolomics analysis
Key secondary outcomes
- Height and body weight
- External characteristics of stool (color and shape)
- Acidity of stool
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 2 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Infants who are breast-fed by own mother.
2) Infants born full term (between 37 and 41 weeks).
3) Infants who are delivered vaginally.
4) Infants and their mother who are not receiving regular use of specific medicine.
5) Infants with parent who showed understanding of the study procedures and agreement with participating the study.
Key exclusion criteria
1) Infants with low birth weight (2,499 g or less)
2) Infants who have current medical history/anamnesis of severe disease.
3) Infants or their mother who are currently participating to other clinical trial for medicine or food, or who possibly participate to other such clinical trial.
4) Subjects who have been determined ineligible by principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sasaki |
Organization
Unicharm Corporation
Division name
"kyo-sei shakai" (Convivial Society) Lab
Zip code
769-1602
Address
1531-7 Wadahama, Toyohama, Kannonji, Kagawa, Japan
TEL
+81-875-52-1611
fr-recruit@unicharm.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Unicharm Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metabologenomics, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel
03-5297-5548
IRB@cpcc.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
| 2019 | Year | 08 | Month | 20 | 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
10
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
| 2019 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate the relationship between defecation frequency and intestinal environment in breast-fed infants.
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043036
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
