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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
153
2 pots/day during 28 days
2 pots/day during 28 days
2 pots/day during 28 days
Atlantia Food Clinical Trials
Cork, Ireland
Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
Time frame: Baseline and during the 4th week.
Change in fecal bulk (stool weight) at baseline and after 4 weeks.
Time frame: Baseline and after 4 weeks.
Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
Time frame: 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.
Time frame: Baseline and after 2 and 4 weeks. Validated questionnaire.
Study product satisfaction by questionnaire after 2 and 4 weeks.
Time frame: after 2 and 4 weeks.
Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
Time frame: 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)
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2 pots/day during 28 days