Clinical trial NCT01102036: Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Transit time
constipation
gut regularity
defecation frequency
Colonic transit time
Lead sponsor: Good Food Practice, Sweden
Sponsor class: INDUSTRY
Collaborators: name: Arla Foods
First posted: 2010-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Change in transit time between treatments
timeFrame: February 2010-June 2010
Secondary outcomes:
measure: Change between treatments on Bristol Stool Form (BSF)symptoms scores
timeFrame: February 2010-June2010
measure: Change between treatments on gastrointestinal symptoms according to Bristol Stool Form
timeFrame: February 2010-June 2010
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Good Food Practice
Study officials:
affiliation: Good Food Practice, Uppsala, Sweden
name: Lars Magnusson, CEO
role: STUDY_DIRECTOR
References: