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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in transit time between treatments
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female and Males
- •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
Outcomes
Primary Outcomes
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
- Change between treatments on Bristol Stool Form (BSF)symptoms scores(February 2010-June2010)
- Change between treatments on gastrointestinal symptoms according to Bristol Stool Form(February 2010-June 2010)
Investigators
Birgitta Sundberg
Director clinical trials
Good Food Practice, Sweden