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A clinical trial on the effect of lactulose on improving the intestinal environment.

A randomised, double-blind, placebo-controlled crossover clinical trial on the effect of lactulose on improving the intestinal environment. - A clinical trial on the effect of lactulose on improving the intestinal environment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044272
Enrollment
36
Registered
2021-05-20
Start date
2021-05-21
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

Sponsors

Megurodoori Gastrointestinal Surgery Internal Medicine Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ?Persons who defecate 3 to 7 days par week ?Persons with bifidobacteria in the intestines

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 use medicines or supplements that may influence feces frequency; e.g. antibiotics, probiotics, laxatives, antidiarrheals, fibers. 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

MeasureTime frame
Bifidobacterium occupancy in feces

Secondary

MeasureTime frame
Stool bacterial flora, stool bifidobacterial count, defecation frequency, the days of defecation, stool properties, defecation volume, strength of defecation, defecation time.

Countries

Japan

Contacts

Public ContactYosuke Inaba

3H Clinical Trial Co., Ltd. Patient Recruitment Group

info@c-trial.com03-5985-0053

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026