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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036803
Receipt No. R000041937
Scientific Title The effect of lactulose on gasses emanating from skin surface. Randomized double-blind, placebo-controlled crossover study.
Date of disclosure of the study information 2019/05/23
Last modified on 2019/05/20

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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
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 Enrolling by invitation
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
2019 Year 05 Month 20 Day


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

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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