A clinical trial on the effect of lactulose on defaecation frequency.

A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on increasing defaecation frequency. - A clinical trial on the effect of lactulose on increasing defaecation frequency.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050599

Enrollment

Registered

2023-03-15

Start date

2023-03-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

None listed

Interventions

Intake of lactulose 4g/day for 2 weeks Intake of placebo for 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Persons who defaecate 2 to 4 times per week

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
defaecation frequency	—

Secondary

Measure	Time frame
faecal microbiota	—

Countries

Japan

Contacts

Public ContactKatsuya Furuhata

Matsumoto Health Lab None

info@m-health-lab.jp0263-39-1139

Outcome results