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

NCT01102036 | Completed

• 1 other identifier: C-X-Ray U-09-017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Transit time; constipation; gut regularity; defecation frequency; Colonic transit time

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change between treatments on Bristol Stool Form (BSF)symptoms scores

  February 2010-June2010

• Change between treatments on gastrointestinal symptoms according to Bristol Stool Form

  February 2010-June 2010

Study Arms (2)

Yoghurt without probiotics

PLACEBO COMPARATOR

Yoghurt without probiotic bacteria

Other: Yoghurt without probiotics

Cultura yoghurt

ACTIVE COMPARATOR

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

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

Interventions

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

2 weeks consumption,250 ml/day

Also known as: Cultura probiotic yoghurt, Yoghurt without prbiotics

Cultura yoghurt

Yoghurt without probiotics OTHER

Yoghurt without probiotics

Yoghurt without probiotics

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Good Food Practice, Sweden: lead
• Arla Foods: collaborator

Study Sites (1)

Good Food Practice

Uppsala, 751 83, Sweden

Location

MeSH Terms

Conditions

Constipation

Interventions

Yogurt; Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages; Dietary Supplements

Study Officials

• Lars Magnusson, CEO

  Good Food Practice, Uppsala, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director clinical trials

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 26, 2011

Record last verified: 2010-04

Locations

SE (1)