Chronic constipation Digestive System Constipation
Conditions
Interventions
The study design determined a 15-day run-in phase without any drug or rescue laxatives and a 21-day controlled treatment period. On the first day of the controlled treatments period (Day 0) enrolled p
Sponsors
Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meet Rome II diagnostic criteria for chronic constipation characterised by: 1.1. A frequency of less than or equal to two bowel movements/week 1.2. Hard stool 1.3. Straining with occasional pain in more than 25% of bowel movements 2. Aged over 18 years, either sex
Exclusion criteria
Exclusion criteria: 1. Cardiac, pulmonary, renal, liver failure 2. Abnormal blood chemistries 3. Known antibiotic allergies In patients who were younger than 50 years and had no other complaint than chronic constipation and the physical examination and routine body chemistries were normal, it was assumed the diagnostic of functional constipation and no special gastrointestinal exams were performed. Patients greater than or equal to 50 years or with lower gastrointestinal bleeding underwent colon radiology or colonoscopy to rule out organic colorectal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between treatments in the mean bowel frequency, straining, stool consistency and pain during defecation at baseline (Day 0) and by the end of treatment period (Day 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Argentina
Outcome results
None listed