Skip to main content
OpenTrials
Completed

NCT Number: NCT01127828

Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes

To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Signed consent to participate age 18-70 years IBS according to Rome II criteria

-

Exclusion criteria

  • Participation in a clinical study one month prior to screening visit and throughout the study.
  • Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
  • Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
  • Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
  • Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
  • Severe psychiatric disease as judged by the investigator.
  • Previous history of drug or alcohol abuse six months prior to screening.
  • Intolerance or allergy against milk products or gluten.
  • Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
  • Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
  • Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
  • Pregnant or lactating or wish to become pregnant during the period of the study.
  • Lack of suitability for participation in the study for any reason as judged by the investigator.

Treatment and study plan

Arla Yoghurt with no probiotic

Other

two servings of 200 ml of investigational products per day

Probiotic yoghurt (Cultura)

Other

200 ml per day

Primary outcomes

  1. Relief of IBS symptoms

    Time frame: 6 weeks intervention and 6 weeks follow up

    The primary endpoint of this study was the proportions of patients reporting adequate relief of their IBS symptoms at least 50 % of the weeks during the treatment period

Secondary outcomes

  1. Effects on gastrointestinal and extraintestinal symptoms

    Time frame: September 2005 to May 2006

    effects of the investigational products on GI and extraintestinal symptoms assessed with the weekly IBS SSI questionnaire and the scores from the daily questions of the GI symptom questionnaire as weel as the effect on psychological symptoms and quality of life.

Sponsors and collaborators

Lead sponsor

Good Food Practice, Sweden

Industry

Registry information

Official study title

Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 21, 2010
Registry last updated
May 24, 2010

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.

Published trials that share one or more normalized conditions with this study.