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

NCT ID: NCT01102036

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-06-30

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

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Yoghurt without probiotics

Yoghurt without probiotic bacteria

Group Type: PLACEBO_COMPARATOR

Yoghurt without probiotics

Intervention Type: OTHER

Yoghurt without probiotics

Cultura yoghurt

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

2 weeks consumption,250 ml/day

Interventions

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

2 weeks consumption,250 ml/day

Intervention Type: OTHER

Yoghurt without probiotics

Yoghurt without probiotics

Intervention Type: OTHER

Other Intervention Names

Cultura probiotic yoghurt; Yoghurt without prbiotics

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arla Foods

INDUSTRY

Sponsor Role: collaborator

Good Food Practice, Sweden

INDUSTRY

Sponsor Role: lead

Responsible Party

Birgitta Sundberg

Director clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Magnusson, CEO

Role: STUDY_DIRECTOR

Good Food Practice, Uppsala, Sweden

Locations

Good Food Practice

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

C-X-Ray U-09-017

Identifier Type: -

Identifier Source: org_study_id