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

This study has been completed.
Sponsor:
Information provided by:
Good Food Practice, Sweden
ClinicalTrials.gov Identifier:
NCT01127828
First received: May 20, 2010
Last updated: May 21, 2010
Last verified: May 2010

May 20, 2010
May 21, 2010
September 2005
May 2006   (final data collection date for primary outcome measure)
Relief of IBS symptoms [ Time Frame: 6 weeks intervention and 6 weeks follow up ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01127828 on ClinicalTrials.gov Archive Site
Effects on gastrointestinal and extraintestinal symptoms [ Time Frame: September 2005 to May 2006 ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Relief of Irritable Bowel Syndrome Symptoms
  • Quality of Life
  • Other: Arla Yoghurt with no probiotic
    two servings of 200 ml of investigational products per day
    Other Name: Arla yoghurt with no probiotic
  • Other: Probiotic yoghurt (Cultura)
    200 ml per day
  • Active Comparator: Probiotic yoghurt (Cultura)
    Cultura yoghurt containing: L bulgaricus, S thermophilus
    Intervention: Other: Probiotic yoghurt (Cultura)
  • Placebo Comparator: Yoghurt with no probiotic
    Intervention: Other: Arla Yoghurt with no probiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01127828
U-05-008
No
Magnus Simrén, Sahlgrenska University Hospital
Good Food Practice, Sweden
Not Provided
Principal Investigator: Magnus Simrén, Ass Prof Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Principal Investigator: Magnus Simren, Ass prof. Sahlgrenska hospital, Gothenburg, Sweden
Principal Investigator: Magnus Simrén, Ass proff Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Good Food Practice, Sweden
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP