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

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cultura L casei F19, acidophilus La5 , B lactis Bb 12
Yoghurt without probiotics
Sponsored by
Good Food Practice, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Transit time, constipation, gut regularity, defecation frequency, Colonic transit time

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Good Food Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Yoghurt without probiotics

Cultura yoghurt

Arm Description

Yoghurt without probiotic bacteria

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
April 8, 2010
Last Updated
August 25, 2011
Sponsor
Good Food Practice, Sweden
Collaborators
Arla Foods
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1. Study Identification

Unique Protocol Identification Number
NCT01102036
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Good Food Practice, Sweden
Collaborators
Arla Foods

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Transit time, constipation, gut regularity, defecation frequency, Colonic transit time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoghurt without probiotics
Arm Type
Placebo Comparator
Arm Description
Yoghurt without probiotic bacteria
Arm Title
Cultura yoghurt
Arm Type
Active Comparator
Arm Description
Cultura yoghurt with L casei F19, acidophilus La5 adn B lactis Bb 12
Intervention Type
Other
Intervention Name(s)
Cultura L casei F19, acidophilus La5 , B lactis Bb 12
Other Intervention Name(s)
Cultura probiotic yoghurt, Yoghurt without prbiotics
Intervention Description
2 weeks consumption,250 ml/day
Intervention Type
Other
Intervention Name(s)
Yoghurt without probiotics
Intervention Description
Yoghurt without probiotics
Primary Outcome Measure Information:
Title
Change in transit time between treatments
Description
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
Time Frame
February 2010-June 2010
Secondary Outcome Measure Information:
Title
Change between treatments on Bristol Stool Form (BSF)symptoms scores
Description
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
Time Frame
February 2010-June2010
Title
Change between treatments on gastrointestinal symptoms according to Bristol Stool Form
Description
To determine the effect of Cultura yoghurt on gastrointestinal symptoms according to the Bristol Stool Form (BSF) after 2 weeks treatment of investigational products
Time Frame
February 2010-June 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Magnusson, CEO
Organizational Affiliation
Good Food Practice, Uppsala, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Good Food Practice
City
Uppsala
ZIP/Postal Code
751 83
Country
Sweden

12. IPD Sharing Statement

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

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