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Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women

NCT ID: NCT01388010

Last Updated: 2016-10-27

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

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

Detailed Description

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Conditions

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Healthy Adult Women

Keywords

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probiotics gastrointestinal well being digestive symptoms healthy population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Test product

Arm 1 - Intervention 1 (probiotics)

Group Type EXPERIMENTAL

1-Fermented Probiotic Dairy Product (test)

Intervention Type OTHER

2 = Control product

Arm 2 - Intervention 2 (control)

Group Type OTHER

2-Milk-based non-fermented dairy product(control)

Intervention Type OTHER

Interventions

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1-Fermented Probiotic Dairy Product (test)

Intervention Type OTHER

2-Milk-based non-fermented dairy product(control)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female free-living subject aged from 18 to 60 years.
* Subject with a body mass index between 18 and 30.
* Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
* Subject with normal stool frequency

Exclusion Criteria

* Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…)
* Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
* Subject having taken antibiotics in the last 4 weeks
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subject with known lactose intolerance or immunodeficiency
* Subject with known allergy to product component (milk protein for example)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

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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RPS Research France

Caen, , France

Site Status

Countries

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France

Other Identifiers

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NU325

Identifier Type: -

Identifier Source: org_study_id