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

JRCT ID: jRCTs031180044

Registered date:27/11/2018

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: IBS-D or functional diarrhea
• Date of first enrollment: 11/01/2019
• Target sample size: 50
• Countries of recruitment: no,Japan
• Study type: Interventional
• Intervention(s): The patients receive oral colestimide 1.5g twice per day after meals for 2 weeks

Outcome(s)

• Primary Outcome: Changes in stool frequency before and after colestimide administration

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Misawa Noboru