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A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool.

A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool. - A study of the effects of probiotics on loose stool.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058839
Enrollment
120
Registered
2025-08-26
Start date
2025-08-27
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

Interventions

Intake of test foods for 12 weeks Intake of placebo foods for 12 weeks

Sponsors

Matsumoto City Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants aged 18-64 years at the time of obtaining consent. 2) Participants with loose stool tendency who defecate more than 7 times a week, with more than 50% of stools categorized as 5 or 6 in the Bristol stool scale.

Exclusion criteria

Exclusion criteria: 1) Participants who regularly take medicines that affect the intestinal environment (antibiotics, bowel medicines, laxatives, etc.). 2) Participants who regularly take foods or supplements that contain lactic acid bacteria, bifidobacteria or oligosaccharides, or that affect the intestinal environment. 3) Participants who cannot stop taking health foods, supplements, foods for specified health uses, foods with functional claims, or foods with nutritional function claims which affect the intestinal environment during the study period. 4) Participants receiving treatment for malignant tumors, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases. 5) Participants with a history of digestive tract surgery (except adenoidectomy, appendicitis, etc.). 6) Participants who are diagnosed with, or are suspected of having, irritable bowel syndrome (IBS), functional diarrhea, or functional abdominal pain by principal investigator. 7) Participants with serious drug or food allergies or a history of such allergies. 8) Participants who are pregnant, lactating, or planning to become pregnant during the study period. 9) Participants who regularly drink more than moderate alcohol consumption (pure alcohol equivalent 20 g/day). 10) Participants who smoke habitually 20 or more cigarettes per day. 11) Participants who are expected to experience major changes in their environment during the study period (relocation, job change, etc.). 12) Participants with irregular lifestyle or irregular eating habits. 13) Participants who are planning overseas travel or long-term business trips during the study period. 14) Participants who have participated in other clinical trials within 3 months prior to the date of consent, or who plan to participate in other clinical trials during the study period. 15) Participants who are judged ineligible to this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Stool consistency

Secondary

MeasureTime frame
Stool frequency

Countries

Japan

Contacts

Public ContactKenji Todoriki

Matsumoto Health Lab None

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

Outcome results

None listed

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