Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02461485
• Date of registration: 24/04/2015
• Prospective Registration: Yes
• Primary sponsor: Danone Research
• Public title: Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02461485
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Ireland

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 69 Years
Gender: All

Health Condition(s) or Problem(s) studied

Constipation

Healthy

Intervention(s)

Other: Non fermented Milk Product

Other: Fermented milk product containing Probiotics

Other: Fermented Milk Product containing Probiotics + Fibers W

Other: Fermented Milk Product containing Probiotics + Fibers C

Primary Outcome(s)

Change in fecal bulk (stool weight) at baseline and after 4 weeks. [Time Frame: Baseline and after 4 weeks.]

Study product satisfaction by questionnaire after 2 and 4 weeks. [Time Frame: after 2 and 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.]

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.]

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)]

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.]

Secondary ID(s)

NU373

Source(s) of Monetary Support

Please refer to primary and secondary sponsors