UMIN-CTR Clinical Trial

Basic information
Public title	Effect of lactulose ingestion on ammonia gas emitted from human skin.
Acronym	Effect of lactulose ingestion on ammonia gas emitted from human skin.
Scientific Title	Effect of lactulose ingestion on ammonia gas emitted from human skin.
Scientific Title:Acronym	Effect of lactulose ingestion on ammonia gas emitted from human skin.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the skin ammonia gas emission inhibitory effect of a single ingestion of 4 g of lactulose under protein loading conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Emission flux of Ammonia gas from human skin (AUC)
Key secondary outcomes	Emission flux of Ammonia gas from human skin (Peak value), Stool forms

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single intake of 4g lactulose
Interventions/Control_2	Single intake of placebo
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy people
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, metal allergy, or lactose intolerance. 6) Subjects who participate another study. 7) Subjects who are judged inappropriate for the study by the investigator or the physician.
Target sample size	20

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-shi, Kanagawa
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-shi, Kanagawa
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-shi, Kanagawa
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	2021 Year 02 Month 26 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	2021 Year 02 Month 17 Day
Date of IRB	2021 Year 02 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 26 Day
Last follow-up date	2021 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 26 Day
Last modified on	2021 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049611