Chronic constipation
Conditions
Interventions
Control arm: nutritional guidance only
Prebiotics arm: water soluble dietary fiber intake 10g/day for 4 weeks following nutritional guidance
Probiotics arm: Bifidobacterium longum BB536 (1*10(11) CFU/
Sponsors
Tsujinaka Hospital Kashiwanoha
Clinical Study Support Center, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic Constipation 1)Must include 2 or more of the followings 1. Fewer than 3 spontaneous bowel movements per week 2. Straining during more than one-fourth of defecations 3. Lumpy of hard stool (BSFS1-2) more than one-fourth of defecations 4. Sensation of incomplete evacuation more than one-fourth of defecations 5. Sensation of anorectal obstruction/blockage more than one-fourth of defecations 6. Manual maneuvers to facilitate more than one-fourth of defecations 2) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis 3) Loose stools are rarely present without the use of laxatives Chronic constipation is diagnosed if patients meet criteria 1), 2), and 3).
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete spontaneous bowel movement compared baseline and 4weeks of treatments | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakafumi Maeda
Tsujinaka Hospital Kashiwanoha Department of Surgery
Outcome results
None listed