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

Good Food Practice, Sweden

Status: Completed

Conditions: Irritable Bowel Syndrome; Relief of Irritable Bowel Syndrome Symptoms; Quality of Life

Treatments: Other: Arla Yoghurt with no probiotic; Other: Probiotic yoghurt (Cultura)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127828

U-05-008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic yoghurt (Cultura)

Active Comparator group

Description:

Cultura yoghurt containing: L bulgaricus, S thermophilus

Treatment:

Other: Probiotic yoghurt (Cultura)

Yoghurt with no probiotic

Placebo Comparator group

Treatment:

Other: Arla Yoghurt with no probiotic