UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041470 |
|---|---|
| Receipt number | R000047343 |
| Scientific Title | Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2021/07/05 16:53:35 |
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Basic information
Public title
Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Acronym
Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Scientific Title
Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Scientific Title:Acronym
Examination study of the effect that continuation intake of lactic acid bacteria food for healthy adults gives to abdominal ache, abdominal discomfort and stool shape due to stress for 4 weeks
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects on abdominal ache, abdominal discomfort and stool shape due to stress by male and female who continue to taking test food for 4 weeks who aged older 20 years or less than 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Izumo scale
Key secondary outcomes
(Secondary outcomes)
Defecation survey, special blood test (IL-1beta, IL-6, IL-10, IL-12p70), SF-8 Japanese version, WPAI:GH, intestinal flora test, metabolome analysis
(Safety evaluation)
Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events
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
4-weeks intake of the test food
Interventions/Control_2
4-weeks intake of the placebo food
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)Japanese male and female aged older 20 years or and less than 65 years at the time of the informed consent.
2) Subject who feels stress on a daily basis.
3) Subject who suffering from abdominal ache and diarrhea accompanied by abdominal discomfort.
4) Subject who is judged not to be sick by the doctor's inquiry.
5)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1)Heavy drinker.
2)Subject who is taking medication or under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food.
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness (depression) or sleep disturbance.
7)Subject who has irregular work rhythms such as working at night and shift work.
8)Subject who has extremely irregular lifestyle such as eating and sleeping.
9)Subject who has an unbalanced diet.
10)Subject who are currently undergoing treatment for a digestive system disease that affects intestinal function, or who have a history of surgery or history of digestive system disease (Excluding appendectomy).
11)Subject who has or had a history of inflammatory bowel disease, irritable bowel syndrome, or other diseases that are thought to greatly affect bowel movements.
12)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases.
13)Subject who uses health foods, supplements, and pharmaceuticals that affect bowel function.
14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
15)Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition.
16)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
17)Subject who can't keep the daily records.
18)Subject who is judged as an inappropriate candidate according to the screening data.
19)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Sato |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
530-8288
Address
2-3-18 Nakanoshima Kita-ku Osaka 530-8288, Japan
TEL
050-3133-7669
takumi.sato@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.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
| 2021 | Year | 11 | Month | 26 | 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
60
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
| 2020 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047343
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