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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461485
• Other study ID #: NU373
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: August 21, 2017
• Start date: May 2015
• Est. completion date: October 12, 2016

Study information

• Verified date: August 2017
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 12, 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Healthy

Intervention

Other:
• Fermented milk product containing Probiotics
2 pots/day during 28 days
• Fermented Milk Product containing Probiotics + Fibers C
2 pots/day during 28 days
• Fermented Milk Product containing Probiotics + Fibers W
2 pots/day during 28 days
• Non fermented Milk Product
2 pots/day during 28 days

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.		Baseline and after 4 weeks.
Primary	Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.		Baseline and after 4 weeks.
Primary	Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.		Baseline and during the 4th week.
Primary	Change in fecal bulk (stool weight) at baseline and after 4 weeks.		Baseline and after 4 weeks.
Primary	Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.		Baseline and after 2 and 4 weeks. Validated questionnaire.
Primary	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.
Primary	Study product satisfaction by questionnaire after 2 and 4 weeks.		after 2 and 4 weeks.
Primary	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)