UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050599 |
|---|---|
| Receipt number | R000057631 |
| Scientific Title | A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on increasing defaecation frequency. |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2023/03/15 16:08:36 |
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Basic information
Public title
A clinical trial on the effect of lactulose on defaecation frequency.
Acronym
A clinical trial of lactulose.
Scientific Title
A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on increasing defaecation frequency.
Scientific Title:Acronym
A clinical trial on the effect of lactulose on increasing defaecation frequency.
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 effect of 4 g of lactulose intake on increasing the defaecation frequency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
defaecation frequency
Key secondary outcomes
faecal microbiota
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who defaecate 2 to 4 times per week
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 regularly use medicine that affect the gut microbiota (e.g, antibiotics, active bacterial preparations, laxatives, antidiarrheals), supplements (including lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, etc.), or foods with functional claims that claim to improve the gut microbiota.
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
70
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
info@m-health-lab.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
Matsumoto Health Lab
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
Ethics Committee, Matsumoto Health Lab
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
Tel
0263-39-1139
info@m-health-lab.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
一般財団法人 松本ヘルス・ラボ（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
