Back to results

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

Primary Purpose

Healthy, Constipation

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Fermented milk product containing Probiotics

Fermented Milk Product containing Probiotics + Fibers C

Fermented Milk Product containing Probiotics + Fibers W

Non fermented Milk Product

About this trial

This is an interventional other trial for Healthy focused on measuring adults, moderate constipation

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Atlantia Food Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

1=BOW_01

2=BOW_01 + fiber C

3 =BOW_01 + fiber W

4 = Control

Arm Description

1= Fermented Milk Product containing Probiotics

2= Fermented Milk Product containing Probiotics + Fibers C

3= Fermented Milk Product containing Probiotics + Fibers W

4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.

Outcomes

Primary Outcome Measures

Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.

Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.

Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.

Change in fecal bulk (stool weight) at baseline and after 4 weeks.

Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.

Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.

Study product satisfaction by questionnaire after 2 and 4 weeks.

Adverse events in the week before baseline, at baseline, week 3, 4 and 5.

Secondary Outcome Measures

Full Information

NCT ID

NCT02461485

First Posted

April 24, 2015

Last Updated

August 21, 2017

Sponsor

Danone Research

1. Study Identification

Unique Protocol Identification Number

NCT02461485

Brief Title

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

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

October 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danone Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Constipation

Keywords

adults, moderate constipation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1=BOW_01

Arm Type

Experimental

Arm Description

1= Fermented Milk Product containing Probiotics

Arm Title

2=BOW_01 + fiber C

Arm Type

Experimental

Arm Description

2= Fermented Milk Product containing Probiotics + Fibers C

Arm Title

3 =BOW_01 + fiber W

Arm Type

Experimental

Arm Description

3= Fermented Milk Product containing Probiotics + Fibers W

Arm Title

4 = Control

Arm Type

Placebo Comparator

Arm Description

4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.

Intervention Type

Other

Intervention Name(s)

Fermented milk product containing Probiotics

Intervention Description

2 pots/day during 28 days

Intervention Type

Other

Intervention Name(s)

Fermented Milk Product containing Probiotics + Fibers C

Intervention Description

2 pots/day during 28 days

Intervention Type

Other

Intervention Name(s)

Fermented Milk Product containing Probiotics + Fibers W

Intervention Description

2 pots/day during 28 days

Intervention Type

Other

Intervention Name(s)

Non fermented Milk Product

Intervention Description

2 pots/day during 28 days

Primary Outcome Measure Information:

Title

Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.

Time Frame

Baseline and after 4 weeks.

Title

Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.

Time Frame

Baseline and after 4 weeks.

Title

Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.

Time Frame

Baseline and during the 4th week.

Title

Change in fecal bulk (stool weight) at baseline and after 4 weeks.

Time Frame

Baseline and after 4 weeks.

Title

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.

Title

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.

Title

Study product satisfaction by questionnaire after 2 and 4 weeks.

Time Frame

after 2 and 4 weeks.

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Atlantia Food Clinical Trials

City

Cork

Country

Ireland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs