Constipation, Healthy
Conditions
Keywords
Stool frequency, Bowel motor function, Orafti® Inulin, Dietary Fiber
Brief summary
Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.
Interventions
DIETARY_SUPPLEMENTOrafti® Inulin
Dietary fiber
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
Sponsors
Beneo GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility. * Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months. * Age ≥ 20 and ≤ 75
Exclusion criteria
* Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries. * Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial. * Subjects with stool frequency of \<1 stool every 7 days or more than 3 stools per week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency determined by daily questionnaire | 4 weeks | Stool frequency determined by daily questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency rated according to the Bristol Stool Form Scale | 4 weeks | Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7. |
| Questionnaire on Gastrointestinal characteristics | 4 weeks | Sensation of straining, abdominal discomfort, bloating/distension, passage of gas and feeling of incomplete emptying rated on a 5-point scale (0 = not at all, 1 = very slightly, 2 = slightly, 3 = moderately, 4 = extremely). |
| Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL) | 4 weeks | Severity of each symptom rated on a five-point scale from 0 (not at all / none of the time) to 4 (extremely / all of the time). |
| Faecal microbiota composition determined by illumina sequencing | 4 weeks | Determined by illumina sequencing. |
| Stool metabolite profiling determined by GC/LC-MS | 4 weeks | Determined by GC/LC-MS. |
Countries
Germany
Outcome results
None listed