UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial on the effect of lactulose on improving the intestinal environment.
Acronym	A clinical trial of lactulose.
Scientific Title	A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on improving the intestinal environment.
Scientific Title:Acronym	A clinical trial on the effect of lactulose on improving the intestinal environment.
Region	Japan

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

Objectives
Narrative objectives1	To verify the bifidobacteria growth effect over time when 4 g of lactulose is ingested.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bifidobacterium occupancy in feces
Key secondary outcomes	Stool bacterial flora, stool bifidobacterial count, defecation frequency, the days of defecation, stool properties, defecation volume, strength of defecation, defecation time.

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
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 2 weeks
Interventions/Control_2	Intake of placebo for 2 weeks
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	･Persons who defecate 3 to 7 days par week ･Persons with bifidobacteria in the intestines
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 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	36

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Kawaguchi
Organization	Megurodoori Gastrointestinal Surgery Internal Medicine Clinic
Division name	Doctor's department
Zip code	153-0064
Address	6-1-27 Shimo-Meguro, Meguro-Ku, Tokyo
TEL	03-3713-1117
Email	info@meguro-ikamera.com

Public contact
Name of contact person	1st name Yosuke Middle name Last name Inaba
Organization	3H Clinical Trial Co., Ltd.
Division name	Patient Recruitment Group
Zip code	171-0022
Address	1-13-23 Minamiikebukuro, Toshima-ku, Tokyo
TEL	03-5985-0053
Homepage URL
Email	info@c-trial.com

Sponsor
Institute	Megurodoori Gastrointestinal Surgery Internal Medicine Clinic
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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro, Toshima-ku, Tokyo
Tel	03-6868-7022
Email	jccr-info@jccr.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	医療法人社団 一星会 目黒通り消化器外科・内科クリニック

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 20 Day

Related information
URL releasing protocol	https://doi.org/10.3390/microorganisms10091719
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3390/microorganisms10091719
Number of participants that the trial has enrolled	36
Results	Ingestion of 4 g of lactulose for 3 days increased fecal bifidobacterial occupancy.
Results date posted	2022 Year 12 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy Japanese adult male and female
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 04 Month 30 Day
Date of IRB	2021 Year 05 Month 13 Day
Anticipated trial start date	2021 Year 05 Month 21 Day
Last follow-up date	2021 Year 10 Month 27 Day
Date of closure to data entry	2022 Year 03 Month 18 Day
Date trial data considered complete	2022 Year 04 Month 07 Day
Date analysis concluded	2022 Year 07 Month 22 Day

Other
Other related information

Management information
Registered date	2021 Year 05 Month 20 Day
Last modified on	2022 Year 12 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050563