Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men.

Detailed Description
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Transit time is the time it takes for a substance to pass through the gut. The major part of the transit is spent in the large bowel is therefore mainly a colonic event. It has been observed that slow transit time is associated with high prevalence of large bowel disorders. The objectives of this study is to: determine the effect on mean transit time after 2 weeks intake of a investigational products using radio-opaque sulphate impregnated polyethylene pellets as markers. determine effect of investigational products on total symptom score according to Bristol Stool Form (BSF) determine effect of investigational products in gastrointestinal symptoms determine safety of intake of the investigational products

Official Title
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Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort During 2 Weeks of Treatment in Comparison to Placebo in Healthy Women and Men

Conditions
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Constipation

Intervention / Treatment
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* Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12
* Other: Yoghurt without probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and Males Healthy BMI 19-29 at visit 1 Age 18 and 60 years at visit 1 Defecation 3-4 times per week or every second to third day (Bristol Stool Form) during the run-in Transit time 35 and 72 hours calculated from the abdominal X-ray at visit 3 Signed written informed consent Exclusion Criteria: Use of probiotics food or supplements during the study Past history of digestive disease Previous complicated GI surgery Oral use of antimicrobial medication or antimicrobial prophylaxis 4 weeks prior to screening visit Use of laxatives (medication or dietary supplements) during the study. Pregnant or lactating or wish to become pregnant during the period of the study Lack of suitability for participation in the trial, for any reason, as judged by the personnel at KPL Good Food Practice AB

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Yoghurt without probiotics<br>Yoghurt without probiotic bacteria | Other: Yoghurt without probiotics<br>* Yoghurt without probiotics<br>|
| Active Comparator: Cultura yoghurt<br>Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12 | Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12<br>* 2 weeks consumption,250 ml/day<br>* Other names: Yoghurt without prbiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transit time between treatments | To determine the effect on mean transit time after 2 weeks intake of investigational products using radio-opaque barium sulphate impregnated polyethylen capsules. These capsules will be consumed during 3 days and thereafter an x-ray image will be taken over the bowel. The capsulese will then be calculated to determine the colonic transit time | February 2010-June 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between treatments on Bristol Stool Form (BSF)symptoms scores | To determine the effect of Cultura yoghurt on the total symptom score according to Bristol Stool Form (BSF) scale during 2 weeks of treatment in comparison to placebo in healthy women and men | February 2010-June2010 | 
| Change between treatments on gastrointestinal symptoms according to Bristol Stool Form | To determine the effect of Cultura yoghurt on gastrointestinal symptoms according to the Bristol Stool Form (BSF) after 2 weeks treatment of investigational products | February 2010-June 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transit time, constipation, gut regularity, defecation frequency, Colonic transit time