Constipation Clinical Trial
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
Verified date | April 2010 |
Source | Good Food Practice, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Good Food Practice | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Good Food Practice, Sweden | Arla Foods |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in transit time between treatments | 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 | Yes |
Secondary | Change between treatments on Bristol Stool Form (BSF)symptoms scores | 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 | No |
Secondary | Change between treatments on gastrointestinal symptoms according to Bristol Stool Form | 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 | No |
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