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

August 25, 2011 updated by: Birgitta Sundberg, Good Food Practice, Sweden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 83
        • Good Food Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in transit time between treatments
Time Frame: February 2010-June 2010
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
Time Frame: February 2010-June2010
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
Time Frame: February 2010-June 2010
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Good Food Practice, Sweden

Collaborators

Arla Foods

Investigators

  • Study Director: Lars Magnusson, CEO, Good Food Practice, Uppsala, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-X-Ray U-09-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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