Back to resultsEffects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
Primary Purpose
Irritable Bowel Syndrome, Relief of Irritable Bowel Syndrome Symptoms, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Arla Yoghurt with no probiotic
Probiotic yoghurt (Cultura)
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS (Irritable Bowel Syndrome), Probiotic yoghurt, Symptom severity
Eligibility Criteria
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.
Sites / Locations
- Department of Internal Medicine, Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic yoghurt (Cultura)
Yoghurt with no probiotic
Arm Description
Cultura yoghurt containing: L bulgaricus, S thermophilus
Outcomes
Primary Outcome Measures
Relief of IBS symptoms
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 Outcome Measures
Effects on gastrointestinal and extraintestinal symptoms
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01127828
Brief Title
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
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Good Food Practice, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Relief of Irritable Bowel Syndrome Symptoms, Quality of Life
Keywords
IBS (Irritable Bowel Syndrome), Probiotic yoghurt, Symptom severity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic yoghurt (Cultura)
Arm Type
Active Comparator
Arm Description
Cultura yoghurt containing: L bulgaricus, S thermophilus
Arm Title
Yoghurt with no probiotic
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Arla Yoghurt with no probiotic
Intervention Description
two servings of 200 ml of investigational products per day
Intervention Type
Other
Intervention Name(s)
Probiotic yoghurt (Cultura)
Intervention Description
200 ml per day
Primary Outcome Measure Information:
Title
Relief of IBS symptoms
Description
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
Time Frame
6 weeks intervention and 6 weeks follow up
Secondary Outcome Measure Information:
Title
Effects on gastrointestinal and extraintestinal symptoms
Description
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.
Time Frame
September 2005 to May 2006
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, Ass Prof
Organizational Affiliation
Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magnus Simren, Ass prof.
Organizational Affiliation
Sahlgrenska hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, Ass proff
Organizational Affiliation
Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
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