Constipation, Healthy
Conditions
Keywords
adults, moderate constipation
Brief summary
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
Interventions
OTHERFermented milk product containing Probiotics
2 pots/day during 28 days
OTHERFermented Milk Product containing Probiotics + Fibers C
2 pots/day during 28 days
OTHERFermented Milk Product containing Probiotics + Fibers W
2 pots/day during 28 days
OTHERNon fermented Milk Product
2 pots/day during 28 days
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
Main eligibility criteria (non-exhaustive list) are defined as: * Healthy Caucasian subject of both gender, aged from 18 to 69 years * Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded) * Subjects with moderate constipation defined according to ROME III adapted criteria. * Subjects without ongoing or diagnosed gastrointestinal disease or complications. * Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function. * Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks. | Baseline and after 4 weeks. |
| Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks. | Baseline and after 4 weeks. |
| Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week. | Baseline and during the 4th week. |
| Change in fecal bulk (stool weight) at baseline and after 4 weeks. | Baseline and after 4 weeks. |
| Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks. | Baseline and after 2 and 4 weeks. Validated questionnaire. |
| Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks. | Baseline and after 2 and 4 weeks. Validated questionnaire. |
| Study product satisfaction by questionnaire after 2 and 4 weeks. | after 2 and 4 weeks. |
| Adverse events in the week before baseline, at baseline, week 3, 4 and 5. | Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study) |
Countries
Ireland
Outcome results
None listed