UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043979 |
|---|---|
| Receipt number | R000050231 |
| Scientific Title | Verification of test food-ingesting effects on gut microbiota and IgA |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2021/08/13 17:26:33 |
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Basic information
Public title
Verification of test food-ingesting effects on gut microbiota and IgA
Acronym
Verification of test food-ingesting effects on gut microbiota and IgA
Scientific Title
Verification of test food-ingesting effects on gut microbiota and IgA
Scientific Title:Acronym
Verification of test food-ingesting effects on gut microbiota and IgA
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of effect by the test-food consumption on gut microbiota and IgA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal IgA level
Key secondary outcomes
Gut microbiota
Gut metabolites
Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
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
Consumption of the test food to the subject, 27 tablets a day for 4 weeks.
Interventions/Control_2
Consumption of the placebo food to the subject, 27 tablets 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) At informed consent, male/female subjects aged more than or equal to 20, and less than 65.
(2) Subjects who have a bowel evacuation for 3 to 7 times in a week.
(3) Subjects who show understanding of the study procedures and agreement with participating in the study, by written informed consent prior to the study.
Key exclusion criteria
(1) Subjects who have a plan or who have taken medication within a month before the trial start, which would affect the trial result.
(2) Subjects who are regularly consuming food for specified health uses, food with function claims, supplement and/or health foods which would affects the trial results for more than 3 times a week.
(3) Subjects who are regularly consuming mushrooms for not less than 6 days a week.
(4) Subjects who have difficulty from restricting mushroom-intakes for less than 2 days a week, as well as less than 50 g a week.
(5) Subjects who dislike mushrooms.
(6) Subjects who had undergone appendectomy.
(7) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(8) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(9) Pregnant, possibly pregnant, or lactating women.
(10) Subjects who take excessive alcohol.
(11) Subjects with irregular life style and irregular dietary habit.
(12) Subjects who have food allergy.
(13) Subjects who are planning to receive vaccination during this trial.
(14) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial.
(15-17) Subjects who donated their blood components and/or whole blood as below
- all subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months to this trial.
(18) Males who will be collected in total of their blood (1200 mL) within the last 12 months, after adding the blood amounts planning to be sampled in this trial.
(19) Females who will be collected in total of their blood (800 mL) within the last 12 months, after adding the blood amounts planning to be sampled in this trial.
(20) Others who have been determined ineligible by principal/sub investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
+81-3-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
HOKUTO 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
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
| 2021 | Year | 04 | Month | 21 | 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
| 2021 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050231
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