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

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

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 Overview

• Status: Completed
• Conditions: Healthy; Constipation
• Intervention / Treatment: Other: Fermented milk product containing Probiotics; Other: Fermented Milk Product containing Probiotics + Fibers C; Other: Fermented Milk Product containing Probiotics + Fibers W; Other: Non fermented Milk Product

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1=BOW_01; 1= Fermented Milk Product containing Probiotics	Other: Fermented milk product containing Probiotics; 2 pots/day during 28 days
Experimental: 2=BOW_01 + fiber C; 2= Fermented Milk Product containing Probiotics + Fibers C	Other: Fermented Milk Product containing Probiotics + Fibers C; 2 pots/day during 28 days
Experimental: 3 =BOW_01 + fiber W; 3= Fermented Milk Product containing Probiotics + Fibers W	Other: Fermented Milk Product containing Probiotics + Fibers W; 2 pots/day during 28 days
Placebo Comparator: 4 = Control; 4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.	Other: Non fermented Milk Product; 2 pots/day during 28 days

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Danone Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 12, 2016

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: adults; moderate constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: NU373