Bowel function (unsatisfactory stool frequency) Digestive System Bowel function (unsatisfactory stool frequency)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers 2. Men and women aged between 50 and 75 years 3. Low stool frequency (2 days or more per week without successful bowel movements)
Exclusion criteria
Exclusion criteria: 1. Clinical constipation as defined by the Rome criteria 2. Anatomical cause of reduced bowel function 3. History of colonic or anal surgery 4. Current or recent (<5 years) diagnosis of cancer, coronary heart disease or diabetes 5. Inflammatory bowel diseases (Crohn?s disease, ulcerative colitis) 6. Use of antibiotics, laxatives or diuretics in the last 3 months 7. Current or recent (<3 months) use of opium preparations 8. Any other condition that in the view of the participant?s GP may make the participant unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency measured by diary, kept daily during weeks 1, 3 and 5 of each intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported stool consistency measured using the Bristol scale 2. Patient assessment of constipation (PAC-SYM) questionnaire | — |
Countries
United Kingdom