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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027305
Receipt No. R000031289
Scientific Title Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Date of disclosure of the study information 2017/05/15
Last modified on 2018/11/19

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Basic information
Public title Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Acronym Low dose of lactulose for intestinal function
Scientific Title Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Scientific Title:Acronym Low dose of lactulose for intestinal function
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To research effect of 2 g lactulose for intestinal function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feces frequency
Key secondary outcomes Defecation number of days, Feces hardness, Volume of feces

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 YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of lactulose 2g/day for 2weeks
Interventions/Control_2 Intake of placebo for 2weeks
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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Subjects with feces frequency 2-4 times / week
Key exclusion criteria 1) Subjects with severe hepatic, renal, heart, gastrointestinal, cerebrovascular, endocrine, metabolic or infection diseases.
2) Subjects with the history of gastrointestinal resection.
3) Subjects with gastrointestinal dysfunction such as irritable bowel syndrome or inflammatory bowel disease.
4) Subjects who use medicines or supplements that may influence feces frequency; e.g. antibiotics, probiotics, laxatives, antidiarrheals, fibers.
5) Subjects with milk allergy.
6) Subjects with lactose intolerance
7) Subjects who participate another study.
8) Subjects who are judged inappropriate for the study by the investigator or the physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisakazu Iino
Organization Showa Women's University
Division name Graduate School, Science for Living System
Zip code
Address 1-7-57 Taishido, Setagaya-ku, Tokyo
TEL 03-3411-4828
Email iino@swu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisakazu Iino
Organization Showa Women's University
Division name Graduate School, Science for Living System
Zip code
Address 1-7-57 Taishido, Setagaya-ku, Tokyo
TEL 03-3411-4828
Homepage URL
Email iino@swu.ac.jp

Sponsor
Institute Showa Women's University
Institute
Department

Funding Source
Organization Morinaga Milk Industry 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
2017 Year 05 Month 15 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
2017 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2017 Year 12 Month 07 Day
Date of closure to data entry
2018 Year 04 Month 11 Day
Date trial data considered complete
2018 Year 06 Month 13 Day
Date analysis concluded
2018 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 11 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031289

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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