Efficacy of Bifidobacterium bifidum G9-1 for quality of life in patients with chronic constipatio

Phase 2

• Conditions: Chronic constipation; constipation, probiotics, BBG9-1; D003248

• Registration Number: JPRN-jRCTs031200011
• Lead Sponsor: Misawa Noboru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

(1) Patients who are diagnosed functional constipation by ROME criteria
(2) Patients who are 20 years old or over and under 85
(3) Patients who can exhibit their consent in a document
(4) Patients who have more than one of overall JPAC-QOL score

Exclusion Criteria

(1) Patients who have defecation disorders or are suspected defecation disorders
(2) Patients who are diagnosed mechanical disorders by colonoscopy within five years
(3) Patients who have severe complications
(4) Patients who have history or current evidence of celiac disease or inflammatory bowel disease
(5) Patients who have severe psychiatric disease
(6) Patients who have current evidence of abuse of drugs or alcohol
(7) Patients who have history of bifidobacteria allergies and corn starch allergies
(8) Patients who had taken new drug therapy for constipation within 2 weeks before entry
(9) Patients who had any change in types, dosage,or adiministration of their prescribed drugs for constipation within 2 weeks before entry
(10) Patients who are under treatment with other probiotics
(11) Patients who had taken new drug therapy as opioid and sleeping pills within 2 weeks before entry
(12) Patients who or are going to be participating in other clinical studies
(13) Patients who have history or current evidence of Parkinson's disease
(14) Patients who are judged as inadequately for study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified