UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low dose of lactulose for intestinal function. Randomized double-blind, placebo-controlled crossover study
Title of the study (Brief title)	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	Hisakazu Iino
Organization	Showa Women's University
Division name	Graduate School, Science for Living System
Address	1-7-57 Taishido, Setagaya-ku, Tokyo
TEL	03-3411-4828
Email	iino@swu.ac.jp

Public contact
Name of contact person	Hisakazu Iino
Organization	Showa Women's University
Division name	Graduate School, Science for Living System
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031289