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

NCT ID: NCT02461485

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-12

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1=BOW_01

1= Fermented Milk Product containing Probiotics

Group Type EXPERIMENTAL

Fermented milk product containing Probiotics

Intervention Type OTHER

2 pots/day during 28 days

2=BOW_01 + fiber C

2= Fermented Milk Product containing Probiotics + Fibers C

Group Type EXPERIMENTAL

Fermented Milk Product containing Probiotics + Fibers C

Intervention Type OTHER

2 pots/day during 28 days

3 =BOW_01 + fiber W

3= Fermented Milk Product containing Probiotics + Fibers W

Group Type EXPERIMENTAL

Fermented Milk Product containing Probiotics + Fibers W

Intervention Type OTHER

2 pots/day during 28 days

4 = Control

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

Group Type PLACEBO_COMPARATOR

Non fermented Milk Product

Intervention Type OTHER

2 pots/day during 28 days

Interventions

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Fermented milk product containing Probiotics

2 pots/day during 28 days

Intervention Type OTHER

Fermented Milk Product containing Probiotics + Fibers C

2 pots/day during 28 days

Intervention Type OTHER

Fermented Milk Product containing Probiotics + Fibers W

2 pots/day during 28 days

Intervention Type OTHER

Non fermented Milk Product

2 pots/day during 28 days

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantia Food Clinical Trials

Cork, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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NU373

Identifier Type: -

Identifier Source: org_study_id

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