UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047766 |
|---|---|
| Receipt number | R000054460 |
| Scientific Title | Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency |
| Date of disclosure of the study information | 2022/05/18 |
| Last modified on | 2023/04/04 10:45:06 |
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Basic information
Public title
Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Acronym
Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Scientific Title
Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Scientific Title:Acronym
Evaluation of effects of test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of the test food intake on fecal properties and intestinal environment of volunteers with loose stool tendency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status (fecal properties)
Key secondary outcomes
Defecation status (the number of days of defecation, quantity of defecation, frequency of defecation, color of stool, feeling of residual stool during defecation, abdominal pain during defecation, odor)
Intestinal microbiota
Intestinal metabolites
Blood LPS
GSRS (Gastrointestinal Symptom Rating Scale)
SF-8
Abdominal symptoms (distention, rumbling, and gas) at times other than defecation
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Ingestion of the test capsules with water for 4 weeks > washout period for 4 weeks > ingestion of the placebo capsules with water for 4 weeks
Interventions/Control_2
Ingestion of the placebo capsules with water for 4 weeks > washout period for 4 weeks > ingestion of the test capsules with water 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. Men and women between the ages of 20 and 64 at the moment of consent
2. Those with loose stool tendency who meet the next two conditions: (1) Who defecate more than 7 times a week; (2) who defecate stools which are categorized as 6 or 7 in the Bristol scale more than once a week
3. Those who have received a full explanation of the study, can understand the contents, and can give a written consent.
Key exclusion criteria
(1) Those who have consumed or will consume oligosaccharide-containing foods for specified health uses or health foods one month before start of test food consumption
(2) Those who regularly consume food for specified health use, or health foods that potentially affect the study at least 3 times a week
(3) Those who regularly consume foods that potentially affect the test food more than 3 times a week
(4) Those who will have taken any medication that will affect the study one month before the pre-test
(5) Those who are lactose intolerant
(6) Patients with a history of appendectomy
(7) Those who underwent surgery that may have affected the study within six months before obtaining consent
(8) Heavy alcohol drinkers
(9) Those who are planning major changes in their environment during the study period
(10) Those with irregular eating habits or irregular lifestyle
(11) Those living in the same household who plan to participate in the study
(12) Those who are participating in a clinical trial of another drug or health food within 4 weeks after completion of the study, or planning to participate in another clinical trial after participating in the study
(13) Patients with a history of heart, liver, kidney, or gastrointestinal diseases
(14) Those who are pregnant, lactating, or intending to become pregnant during the study
(15) Those who are allergic to drugs/foods
(16) Those who have donated 200 mL of blood in one month before start of the study
(17) Males who have donated 400 mL of blood within 3 months before start of the study
(18) Females who have donated 400 mL of blood within 4 months before start of the study
(19) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL
(20) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL
(21) Those who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-0052, 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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Shionogi Healthcare 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
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
| 2022 | Year | 05 | Month | 18 | 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 | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 21 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054460
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| Registered date | File name |
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