UMIN-CTR Clinical Trial

Basic information
Public title	The effect of lactulose on gasses emanating from skin surface. Randomized double-blind, placebo-controlled crossover study.
Acronym	The effect of lactulose on gasses emanating from skin surface.
Scientific Title	The effect of lactulose on gasses emanating from skin surface. Randomized double-blind, placebo-controlled crossover study.
Scientific Title:Acronym	The effect of lactulose on gasses emanating from skin surface.
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 4 g lactulose for ammonia emanating from skin surface.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Emission flux of ammonia from skin surface
Key secondary outcomes	Emission flux of gasses except ammonia from skin surface

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 4g/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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy subject
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	30

Research contact person
Name of lead principal investigator	1st name Yoshika Middle name Last name Sekine
Organization	Tokai University
Division name	Graduate School of Science
Zip code	259-1207
Address	4-1-1 Kitakaname, Hiratsuka-City, Kanagawa-Prefecture
TEL	0463-58-1211
Email	sekine@keyaki.cc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Sekine
Organization	Tokai University
Division name	Graduate School of Science
Zip code	259-1207
Address	4-1-1 Kitakaname, Hiratsuka-City, Kanagawa-Prefecture
TEL	0463-58-1211
Homepage URL
Email	sekine@keyaki.cc.u-tokai.ac.jp

Sponsor
Institute	Tokai 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	TOKAI DAIGAKU " hito wo taisho to suru kenkyu"ni kansuru rinriiinnkai
Address	4-1-1 Kitakaname, Hiratsuka-City, Kanagawa-Prefecture
Tel	0463-58-1211
Email	sekine@keyaki.cc.u-tokai.ac.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	2019 Year 05 Month 23 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	30
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	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 04 Month 22 Day
Anticipated trial start date	2019 Year 05 Month 24 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 20 Day
Last modified on	2020 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041937