UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044272 |
|---|---|
| Receipt number | R000050563 |
| Scientific Title | A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on improving the intestinal environment. |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2022/12/08 14:36:44 |
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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
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
info@c-trial.com
Sponsor or person
Institute
Megurodoori Gastrointestinal Surgery Internal Medicine Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050563
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| Registered date | File name |
| Research case data | |
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