UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055346 |
|---|---|
| Receipt number | R000063083 |
| Scientific Title | A study on the safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup in human |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/09/29 15:25:26 |
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Basic information
Public title
The safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup in human
Acronym
The safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup
Scientific Title
A study on the safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup in human
Scientific Title:Acronym
The safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup
Region
| Japan |
Condition
Condition
Transitory hyperosmotic laxative effect
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the maximum dose of single intake of oligosaccharide syrup, which is a test substance, without inducing transitory hyperosmotic laxative action.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum dose of intake of oligosaccharide syrup that does not induce transitory hyperosmotic laxative effect, observation of laxative effect.
Key secondary outcomes
Defecation status, gastrointestinal symptoms and breath hydrogen gas excretion associated with ingestion of the test substance.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion.
Control (reference) test substance (nondigestible oligosaccharide) 5 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the control test substance is stopped.
Interventions/Control_2
Oral ingestion.
Control (reference) test substance (nondigestible oligosaccharide) 10 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the control test substance is stopped.
Interventions/Control_3
Oral ingestion.
Control (reference) test substance (nondigestible oligosaccharide) 15 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the control test substance is stopped.
Interventions/Control_4
Oral ingestion.
Control (reference) test substance (nondigestible oligosaccharide) 20 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the control test substance is stopped.
Interventions/Control_5
Oral ingestion.
Control (reference) test substance (nondigestible oligosaccharide) 25 g.
Interventions/Control_6
Oral ingestion.
The test substance (oligosaccharide syrup) 10 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the test substance is stopped.
Interventions/Control_7
Oral ingestion.
The test substance (oligosaccharide syrup) 20 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the test substance is stopped.
Breath gas samples were collected up to seven hours after subjects ingested the test substance. These subjects did not experience transitory hyperosmotic laxative effects after consuming 50 g of oligosaccharide syrup.
Interventions/Control_8
Oral ingestion.
The test substance (oligosaccharide syrup) 30 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the test substance is stopped.
Interventions/Control_9
Oral ingestion.
The test substance (oligosaccharide syrup) 40 g.
In the case of transitory hyperosmotic laxative induction, the continuation of the test for ingestion of the test substance is stopped.
Interventions/Control_10
Oral ingestion.
The test substance (oligosaccharide syrup) 50 g.
Breath gas samples were collected up to seven hours after subjects ingested the test substance. These subjects did not experience transitory hyperosmotic laxative effects after consuming 50 g of oligosaccharide syrup.
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Normal, adult
2. Japanese
Key exclusion criteria
A person who
1. has a history of gastrointestinal diseases or diseases
2. often develops diarrhea
3. has food allergies (especially milk and dairy products)
4. has impaired glucose tolerance, such as diabetes mellitus
5. has carbohydrate-related metabolic diseases (especially lactose intolerance)
6. taking antibacterial agents or regularly using laxatives
7. has a history of malignancy or heart disease, or are undergoing treatment
8. BMI of 30 or more, or less than 17
9. had participated in other clinical trials in the 28 days prior to submission of consent to this study
10. smoker
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Sadako |
| Middle name | |
| Last name | Nakamura |
Organization
Jumonji University
Division name
Graduate School of Human Life Sciences/ Dept. Food Science, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
TEL
0484770555
nacsacj@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Sadako |
| Middle name | |
| Last name | Nakamura |
Organization
Jumonji University
Division name
Graduate School of Human Life Sciences/ Dept. Food Science, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
TEL
0484770555
Homepage URL
nacsacj@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee of Research Ethics, Division of Research Support, Jumonji University
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
Tel
148-477-0555
k-kenkyu@jumonji-u.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
十文字学園女子大学、中村学園大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to reviewing the plan change for additional testing (confirmation of breath gas excretion concentration) at Jumonji University, separate review was conducted for additional testing at Nakamura Gakuen University, with Nakamura Gakuen University acting as the representative institution, and approval number (25-003) was obtained.
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063083
