Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Not Applicable
- Conditions
- Chronic constipation
- Registration Number
- JPRN-UMIN000027429
- Lead Sponsor
- Tsujinaka Hospital Kashiwanoha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) rectal intussuspocion, rectal prolapse, and megacolon inducing constipation 2) secondary constipation due to psychiatric disorders, neurologic disorders, endcrine disorders, or medication (opioids, antidepressants, anticholinergic, calcium channel blockers, proton pump inhibitors) 3)mechanical obstruction 4)past history of inflammatory bowel diseases, colorectal cancer, or bowel obstruction 5)pregnant of lactating woman 6)renal failure (serum Cr>=2.0mg/dl), severe liver disorder (T-Bil >=3.0mg/dl or AST, ALT>=100U/L) 7)severe cardiovascular disorders 8)physician determined ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete spontaneous bowel movement compared baseline and 4weeks of treatments
- Secondary Outcome Measures
Name Time Method spontaneous bowel movement, Bristol Stool Form Scale, Constipation Scoring System (CSS), The Patient Assesment of Constipation Quality of Life (PAC-QOL), Gastrointestinal Symptoms Rating Scale (GSRS), evacuation symptoms (straining, sensation of incomplete evacuation, pain, and satisfaction), and amount of dietary fiber intake per day after 4weeks of treatments