Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms

Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms - Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058028

Enrollment

Registered

2025-06-07

Start date

2025-06-07

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Healthy volunteers

Interventions

Oral

12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: 1) Individuals currently undergoing any form of medication or outpatient treatment 2) Individuals currently receiving medical treatment at a medical institution for a digestive disease that may affect intestinal function, or those with a history of gastrointestinal surgery (excluding appendectomy) 3) Individuals with a history of diseases such as ulcerative colitis that may significantly affect bowel movements 4) Individuals who have been diagnosed with irritable bowel syndrome as the cause of diarrhea accompanied by abdominal pain and discomfort 5) Individuals who regularly use over-the-counter medicines or quasi-drugs for the prevention or treatment of diarrhea with abdominal pain or discomfort 6) Individuals currently receiving outpatient treatment specifically for diarrhea accompanied by abdominal pain or discomfort 7) Individuals who regularly use nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or antibiotics 8) Individuals with severe diarrhea accompanied by abdominal pain and discomfort, who are deemed by the principal investigator to require medical treatment 9) Individuals with a history of drug or food allergies (e.g., milk) 10) Individuals who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period 11) Individuals currently receiving treatment for mental disorders (e.g., depression) or sleep disorders, or those with a history of psychiatric treatment 12) Individuals with extremely irregular lifestyle habits, such as inconsistent eating and sleeping patterns 13) Individuals currently participating in another clinical trial or who have participated in one within the past month 14) Individuals who may have difficulty complying with various questionnaires or maintaining study-related records 15) Any other individuals deemed unsuitable for the study by the principal investigator

Design outcomes

Secondary

Measure	Time frame
Stool consistency (Bristol Stool Form Scale), Abdominal symptoms, Test food intake record, Abdominal symptoms questionnaire GSRS Bowel movement frequency WPAI SF-8 POMS2 short version	—

Primary

Measure	Time frame
Subject's global assessment	—

Countries

Japan

Contacts

Public ContactTatsuo Uetake

CXwellness, Inc. Representative Directo

uetake@cx-wellness.com03-6915-5507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026