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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047766
Receipt No. 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 2022/05/16

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 05 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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