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Completed

NCT Number: NCT01102036

Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Good Food Practice

Uppsala, 751 83, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cultura L casei F19, acidophilus La5 , B lactis Bb 12

Other

2 weeks consumption,250 ml/day

Other names: Cultura probiotic yoghurt, Yoghurt without prbiotics

Yoghurt without probiotics

Other

Yoghurt without probiotics

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Good Food Practice, Sweden

Industry

Collaborators

  • Arla Foods

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2010
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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