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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044037
Receipt No. R000050284
Scientific Title Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-
Date of disclosure of the study information 2021/05/07
Last modified on 2021/04/26

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Basic information
Public title Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-
Acronym Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition.
Scientific Title Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-
Scientific Title:Acronym Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This trial aims to investigate the effect of continuous consumption of the test food on immunological markers, fecal odors, and fecal condition on healthy adults.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immunological markers
Questionnaire for fecal conditions
Questionnaire for physical conditions
fecal condition markers (including fecal odors)
gut microbiota
Key secondary outcomes

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 Take 1 packet of the test food before sleeping once per day.
Interventions/Control_2 Take 1 packet of the placebo food before sleeping once per day.
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Age between 40 and 70 years at the time of informed consent
2.Japanese male or female
3.Those who have contracted an upper respiratory infection every year.
4.Those who are able to input electronic diary with smartphone / PC
5.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria 1.Those who has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease.
2.On diet / exercise therapy under the guidance of a doctor
3.Have a current or history of serious illness
4.Those who have allergic dermatitis, (perennial/seasonal) allergic rhinitis, bronchial asthma, and chronic bronchitis.
5.Those who have currently been taking drugs, quasi-drug products, and foods or supplements which have health claims. However, those who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial.
6.Those who have a current or previous history of drug and/or food allergies
7.Take lactic acid bacteria drinks, yogurt or supplements containing lactic acid bacteria daily.
8.Excessive consumption of alcohol (alcohol equivalent 60g or more / day)
9.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial.
10.Those who are planning travels to foreign countries during the trial period.
11.Irregular diet, shift worker, night shift, irregular life rhythm
12.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period.
13.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate.
14.Those who were determined by the investigator to be unsuitable for participation in this clinical trial.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mariko
Middle name
Last name Okamori
Organization Nichinichi pharmaceutical Co., Ltd
Division name Central Research Laboratory
Zip code 519-1413
Address 239-1 Tominaga, Iga-city, Mie 518-1417
TEL 0595-48-0201
Email lab@nichinichi-phar.co.jp

Public contact
Name of contact person
1st name Hirokuni
Middle name
Last name Kayama
Organization IMEQRD Co., Ltd
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo Japan
TEL 03-6704-5968
Homepage URL
Email h-kayama@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

Funding Source
Organization Nichinichi Pharmaceutical 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 Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6704-5968
Email n-yuzawa@imeqrd.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 05 Month 07 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
2021 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 12 Day
Last follow-up date
2021 Year 09 Month 05 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 26 Day
Last modified on
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050284

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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