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

Good Food Practice, Sweden

Status: Completed

Conditions: Constipation

Treatments: Other: Yoghurt without probiotics; Other: Cultura L casei F19, acidophilus La5 , B lactis Bb 12

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102036

C-X-Ray U-09-017

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Yoghurt without probiotics

Placebo Comparator group

Description:

Yoghurt without probiotic bacteria

Treatment:

Other: Yoghurt without probiotics

Cultura yoghurt

Active Comparator group

Description:

Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12

Treatment:

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