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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102036
• Other study ID #: C-X-Ray U-09-017
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: August 25, 2011
• Start date: February 2010
• Est. completion date: June 2010

Study information

• 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

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• Cultura L casei F19, acidophilus La5 , B lactis Bb 12
2 weeks consumption,250 ml/day
• Yoghurt without probiotics
Yoghurt without probiotics

Locations

Country	Name	City	State
Sweden	Good Food Practice	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Good Food Practice, Sweden	Arla Foods

Country where clinical trial is conducted

Sweden, 

Outcome

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