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OpenTrials
Completed

NCT Number: NCT01097993

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)

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).

Completed

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Manchester Hospital

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • Age: 18-70

Exclusion criteria

  • NA

Treatment and study plan

1-fermented dairy product

Other

Arm 1 - Intervention 1 (probiotics)

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

Other

Arm 2 - Intervention 2 (control)

Primary outcomes

  1. Mean abdominal distension after a 4-week period of product consumption in IBS-C patients

    Time frame: 0-4 weeks

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Apr 2, 2010
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.