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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
  Purpose

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.


Condition Intervention
Constipation
 Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12
Other: Yoghurt without probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Good Food Practice, Sweden:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Yoghurt without probiotics
Yoghurt without probiotic bacteria
 Other: Yoghurt without probiotics
Yoghurt without probiotics
Active Comparator: Cultura yoghurt
Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12
 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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102036

Locations
Sweden
Good Food Practice
Uppsala, Sweden, 751 83
Sponsors and Collaborators
Good Food Practice, Sweden
Arla Foods AB, Sweden
Investigators
Study Director: Lars Magnusson, CEO Good Food Practice, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Birgitta Sundberg, Director clinical trials, Good Food Practice, Sweden
ClinicalTrials.gov Identifier: NCT01102036     History of Changes
Other Study ID Numbers: C-X-Ray U-09-017
Study First Received: April 8, 2010
Last Updated: August 25, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Good Food Practice, Sweden:
Transit time
constipation
gut regularity
defecation frequency
Colonic transit time

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013