A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT ID: NCT01097993

Last Updated: 2017-01-20

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-01-31

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 abdominal distension in IBS patients with constipation (IBS-C).

Detailed Description

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Conditions

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Women With IBS-C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type EXPERIMENTAL

1-fermented dairy product

Intervention Type OTHER

Arm 1 - Intervention 1 (probiotics)

2 = Control product

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Arm 2 - Intervention 2 (control)

Interventions

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1-fermented dairy product

Arm 1 - Intervention 1 (probiotics)

Intervention Type OTHER

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

Arm 2 - Intervention 2 (control)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* female
* Age: 18-70

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Manchester Hospital

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NU324

Identifier Type: -

Identifier Source: org_study_id

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