Clinical trial NCT01127828: Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
Official title: Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Relief of Irritable Bowel Syndrome Symptoms
Quality of Life
Keywords: IBS (Irritable Bowel Syndrome)
Probiotic yoghurt
Symptom severity
Lead sponsor: Good Food Practice, Sweden
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

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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.

Primary outcomes:
measure: Relief of IBS symptoms
timeFrame: 6 weeks intervention and 6 weeks follow up
Secondary outcomes:
measure: Effects on gastrointestinal and extraintestinal symptoms
timeFrame: September 2005 to May 2006
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Internal Medicine, Sahlgrenska University Hospital
Study officials:
affiliation: Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
name: Magnus Simrén, Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska hospital, Gothenburg, Sweden
name: Magnus Simren, Ass prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
name: Magnus Simrén, Ass proff
role: PRINCIPAL_INVESTIGATOR
References: