Clinical trial NCT02461485: Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms
Official title: Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Constipation
Keywords: adults
moderate constipation
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
timeFrame: Baseline and after 4 weeks.
measure: Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
timeFrame: Baseline and after 4 weeks.
measure: Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
timeFrame: Baseline and during the 4th week.
measure: Change in fecal bulk (stool weight) at baseline and after 4 weeks.
timeFrame: Baseline and after 4 weeks.
measure: Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
timeFrame: Baseline and after 2 and 4 weeks. Validated questionnaire.
measure: Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.
timeFrame: Baseline and after 2 and 4 weeks. Validated questionnaire.
measure: Study product satisfaction by questionnaire after 2 and 4 weeks.
timeFrame: after 2 and 4 weeks.
measure: Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
References: