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

JRCT ID: jRCTs031200011

Registered date:13/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 28/07/2020
• Target sample size: 150
• Study type: Interventional
• Intervention(s): The patients receive oral Bifidobacterium bifidum G9-1 or placebo third per day after meals for 8 weeks

Outcome(s)

• Primary Outcome: The change in JAPAC-QOL score form pre to after 8 weeks intervention

Secondary Outcome

The change in JPAC-QOL score from pre-to after 4 weeks intervention
The comparison of stool form,degree of sense of incomplete evacuation,degree of straining, days of defecation and frequency of internal use of rescue drugs between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention
The drug compliance
Correlation between PAC-QOL score and change in number of days of defecation, stool form, degree of sense of incomplete evacuation and degree of straining

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Misawa Noboru
• Source(s) of Monetary Support: Biofermin Pharmaceutical Co