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The safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup in human

A study on the safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup in human - The safety evaluation of transitory hyperosmotic laxative effects by oligosaccharide syrup

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055346
Enrollment
25
Registered
2024-08-30
Start date
2024-09-17
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitory hyperosmotic laxative effect

Interventions

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 c

Sponsors

Jumonji University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Normal, adult 2. Japanese

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maximum dose of intake of oligosaccharide syrup that does not induce transitory hyperosmotic laxative effect, observation of laxative effect.

Secondary

MeasureTime frame
Defecation status, gastrointestinal symptoms and breath hydrogen gas excretion associated with ingestion of the test substance.

Countries

Japan

Contacts

Public ContactSadako Nakamura

Jumonji University Graduate School of Human Life Sciences/ Dept. Food Science, Faculty of Human Life

nacsacj@jumonji-u.ac.jp0484770555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026