The study of therapy to diarrhea symptoms by the bile acid sequestrants

The study of novel therapy for patients who have intractable diarrhea symptoms by the bile acid sequestrants - The study of novel therapy for patients who have intractable diarrhea symptoms by the bile acid sequestrants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180044

Enrollment

Registered

2018-11-27

Start date

2019-01-11

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

IBS-D or functional diarrhea

Interventions

The patients receive oral colestimide 1.5g twice per day after meals for 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are diagnosed IBS-D or functional diarrhea by ROME criteria and have treatment for the diarrhea within 4 weeks before entry (2) Patients who have more than three defecation or more than bristol score 6 per day (3) Patients who are excluded mechanical disorders by colonoscopy within five years (4) Patients who are 20 years old or over and under 80

Exclusion criteria

Exclusion criteria: (1) Patients who have severe complications (2) Patients who had colestimide within 4 weeks before entry (3) Patients who have history of colestimide allergies (4) Patients who are biliary obstruction (5) Patients who are intestinal obstruction (6) Patients who have narrowing of colon lumen (7) Patients who have diverticular disease of intestine (8) Patients who have difficulty of swallowing (9) Patients who have hemorrhoid (10) Patients who have or had gastrointestinal ulcer (11) Patients who have bleeding tendency (12) Patients who have particular drug (13) Patients who have fewer than bristol score 2 (14) Patients who have severe psychiatric disease (15) Patients who have current evidence of abuse of drugs or alcohol (16) Patients who have new therapy for diarrhea within 4 weeks before entry (17) Patients who had taken new drug therapy within 4 weeks before entry (18) Patients who are judged as inadequately for study entry

Design outcomes

Primary

Measure	Time frame
Changes in stool frequency before and after colestimide administration	—

Secondary

Measure	Time frame
Changes in average stool shape before and after colestimide administration Degree of improvement of subjective symptoms after colestimide administration Changes in frequency of rescue medication use before and after colestimide administration Compliance rate of oral colestimide Incidence rate of adverse events Changes in gut microbiota before and after colestimide administration Changes in metabolites in the stool before and after colestimide administration Diversity of intestinal bacteria Changes in C4, FGF19 and amount of bile acid in stool and blood before and after colestimide administration	—

Measure

Time frame

Changes in average stool shape before and after colestimide administration Degree of improvement of subjective symptoms after colestimide administration Changes in frequency of rescue medication use before and after colestimide administration Compliance rate of oral colestimide Incidence rate of adverse events Changes in gut microbiota before and after colestimide administration Changes in metabolites in the stool before and after colestimide administration Diversity of intestinal bacteria Changes in C4, FGF19 and amount of bile acid in stool and blood before and after colestimide administration

—

Countries

Japan, no

Contacts

Public ContactNoboru Misawa

Yokohama City University Hospital

nobomisa@hotmail.co.jp+81-45-787-2640

Outcome results

None listed

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