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

This study has been completed.
Sponsor:
Collaborator:
Arla Foods AB, Sweden
Information provided by (Responsible Party):
Birgitta Sundberg, Good Food Practice, Sweden
ClinicalTrials.gov Identifier:
NCT01102036
First received: April 8, 2010
Last updated: August 25, 2011
Last verified: April 2010
History of Changes

April 8, 2010
August 25, 2011
February 2010
May 2010   (final data collection date for primary outcome measure)
Change in transit time between treatments [ Time Frame: February 2010-June 2010 ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01102036 on ClinicalTrials.gov Archive Site
  • Change between treatments on Bristol Stool Form (BSF)symptoms scores [ Time Frame: February 2010-June2010 ] [ Designated as safety issue: No ]
    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
  • Change between treatments on gastrointestinal symptoms according to Bristol Stool Form [ Time Frame: February 2010-June 2010 ] [ Designated as safety issue: No ]
    To determine the effect of Cultura yoghurt on gastrointestinal symptoms according to the Bristol Stool Form (BSF) after 2 weeks treatment of investigational products
Same as current
Not Provided
Not Provided
 
Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men
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

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Constipation
  • Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12
    2 weeks consumption,250 ml/day
    Other Names:
    • Cultura probiotic yoghurt
    • Yoghurt without prbiotics
  • Other: Yoghurt without probiotics
    Yoghurt without probiotics
  • Placebo Comparator: Yoghurt without probiotics
    Yoghurt without probiotic bacteria
    Intervention: Other: Yoghurt without probiotics
  • Active Comparator: Cultura yoghurt
    Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12
    Intervention: Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01102036
C-X-Ray U-09-017
No
Birgitta Sundberg, Good Food Practice, Sweden
Good Food Practice, Sweden
Arla Foods AB, Sweden
Study Director: Lars Magnusson, CEO Good Food Practice, Uppsala, Sweden
Good Food Practice, Sweden
April 2010

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