UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063073 |
|---|---|
| Receipt number | R000067950 |
| Scientific Title | A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/28 14:30:06 |
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Basic information
Public title
A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition
Acronym
A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition
Scientific Title
A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition
Scientific Title:Acronym
A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition
Region
| Japan |
Condition
Condition
Adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating changes in bowel movements and gut microbiota and physical condition following 8weeks of lactosucrose intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1.Frequency of bowel movements and stool consistency
2.Gut microbiota analysis
3.Body weight and blood tests
4.Skin moisture measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The test food (lactosucrose syrup) will be consumed at 8grams per day for 8 weeks
Interventions/Control_2
The placebo food (mizuame) will be consumed at 8grams per day for 8 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who are 60years old or older
2.Subjects diagnosed with chronic constipation and currently using laxatives
3.Individuals who are able to provide written informed consent to participate in the study,
either personally or through a legal representative, after being informed of the study's purpose and details
Key exclusion criteria
1.Those who are parenteral nutrition management
2.Subjects who showed abnormal abdominal symptoms following intake of the test food
3.Subjects judged to be inappropriate for participation in the study by the principal investigator or a physician involved in the research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Matsumura |
Organization
Kitayama Takeda Hospital, Koseikai Medical Foundation
Division name
Nutrition Department
Zip code
603-8053
Address
99 Kamigamo Iwagakakiuti-cho Kita-ku,Kyoto-shi,Kyoto,Japan
TEL
075-721-1612
eiyo-k@takedahp.or.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Matsumura |
Organization
Doshisha Women's College of Liberal Arts
Division name
Graduate School of Human Life Science, Department of Food and Nutrition
Zip code
602-0893
Address
602 Genbu-cho, Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-251-4211
Homepage URL
is25003@dwc.doshisha.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Doshisha Women's College of Liberal Arts
Address
602 Genbu-cho, Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi, Kyoto, Japan
Tel
075-251-4211
is25003@dwc.doshisha.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067950
