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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035202
Receipt No. R000040114
Scientific Title Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study
Date of disclosure of the study information 2018/12/10
Last modified on 2018/12/11

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Basic information
Public title Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study
Acronym Study of the effect of a drink containing lactic acid bacteria on bowel movement,intestinal flora and fecal properties in subjects with constipation tendency.
Scientific Title Study of the effect of a drink containing lactic acid bacteria on bowel movement, intestinal flora and fecal properties in subjects with constipation tendency. : A randomized, double blinded, placebo controlled study
Scientific Title:Acronym Study of the effect of a drink containing lactic acid bacteria on bowel movement,intestinal flora and fecal properties in subjects with constipation tendency.
Region
Japan South America

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

Objectives
Narrative objectives1 This study aimed to verify the effect of drink containing lactic acid bacteria on bowel movement, fecalproperties in subjects with constipation tendency for 2 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency
Evaluate two weeks after starting ingestion.
Key secondary outcomes Defecation days, Fecal amount, Fecal properties. Intestinal flora(Real-Time PCR). Fecal moisture. Fecal pH. The fecal concentrations of ammonia.

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 Ingestion of test product for 2 consecutive weeks
Interventions/Control_2 Ingestion of placebo for 2 consecutive 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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1)males and females from 20 to 64 years of age
(2)Subjects who answered that the usual defecation frequency was 5 or less per week in the questionnaire
(3)Subjects with constipation tendency and lower defecation frequency during screening period
Key exclusion criteria (1)Subjects who cannot restrict the use of medicines or health foods that may influence their bowel movements after informed consent
(2)Subjects visiting the hospital for diseases related bowel movements and using drugs, or are regularly using commercially available constipation medicine
(3)Subjects currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy)
(4)Subjects with diseases (irritable enteritis, ulcerative colitis,etc.) affecting bowel movement or have a history of these diseases
(5)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(7)Subjects have a deseases requiring regular medication or a history of serious diseases for which medication was required
(8)Subjects have possibilities to develop an allergy to the test product
(9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(11)Subjects who have participated in other clinical studies
(12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(13)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Saito
Organization Medical Station Clinic
Division name None
Zip code
Address 3-12-8 Takabann, Meguro-ku, Tokyo, Japan
TEL 03-6452-2712
Email info@med-station.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiharu Goto
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
TEL 03-5459-5329
Homepage URL
Email c.goto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Nissin York 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
Address
Tel
Email

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
2018 Year 12 Month 10 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 10 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040114

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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