Plain English Summary
Background and study aims
Probiotics are live bacteria and yeasts that are good for your health. They are often found in milk products such as yogurt and as food supplements. It is believed that regular consumption of probiotics has a beneficial effect on the digestive system. This study will investigate whether a capsule with a specific probiotic microorganism can improve intestinal permeability more than a capsule that does not contain probiotics (placebo).
Who can participate?
Healthy men and women aged 18 to 40 who train for 4 or more hours per week and experience
gastrointestinal symptoms that interfere with their training and during competition.
What does the study involve?
Participants are randomly allocated to take either one of two capsules containing two different probiotics or an identical capsule without probiotics (placebo) for 6 weeks. Participants provide urine and fecal samples, undergo exercise tests, and complete questionnaires on quality of life, food habits, physical activity and bowel habits.
What are the possible benefits and risks of participating?
The consumption of the probiotic capsule could lead to a general improvement in the partcipant’s well-being and has no known risks.
Where does the study take place?
Nutrition-Gut-Brain Interactions Research Centre (NGBI), Örebro University, Sweden
When is the study starting and how long is it expected to run for?
January 2015 to February 2016
Who is funding the study?
Chr. Hansen A/S (Denmark)
Who is the main contact?
Prof Robert Brummer
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HND-GI-020
Study information
Scientific title
Investigational study on the effect of 6 weeks intake of two probiotic strains on exercise-induced intestinal permeability – a randomized, double-blind, placebo-controlled, three-armed parallel group study
Acronym
APRO
Study hypothesis
The study was designed to investigate the efficacy of daily consumption of two probiotic strains for 6 weeks on exercise-induced intestinal permeability and supporting biomarkers.
Ethics approval
Regionala etikprövningsnämnden (Regional Ethical Committee) i Uppsala, 18/03/2015 , ref: Dnr 2015/077
Study design
Randomized double-blind placebo-controlled parallel-group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Gastrointestinal function
Intervention
Participants are randomised to one of three treatment arms for six weeks:
1. A capsule containing a probiotic strain A
2. A capsule containing a probiotic strain B
3. A placebo capsule with no probiotics
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Intestinal permeability after a standardized exercise challenge measured by the in vivo lactulose/rhamnose sugar test at baseline and end of intervention (after 6 weeks)
Secondary outcome measures
Multiple potential biomarkers measured in blood, feces and saliva at baseline and end of intervention (after 6 weeks)
Overall trial start date
01/01/2015
Overall trial end date
01/02/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy men or women
2. Age 18 to 40 inclusive
3. Presence of upper or lower gastrointestinal symptoms that interfere with training and during competition
4. Weekly training load of 4 or more hours within endurance sports (minimum 50% of the training should be running activity)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. History of hypersensitivity to any of the ingredients of the study products or lactose intolerance
2. History or diagnosis of gastrointestinal disease or complicated gastrointestinal surgery
3. Any physical or psychological abnormality or medical condition that could have an effect on gastrointestinal discomfort
4. Participation in any other clinical study
5. Not willing or able to provide written informed consent for participation in the study
6. For women: Not willing and able to use a reliable contraceptive method, pregnancy, lactation or wish to become pregnant
Recruitment start date
21/09/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Örebro University
Nutrition-Gut-Brain Interactions Research Centre (NGBI)
701 82
Sweden
Funders
Funder type
Industry
Funder name
Chr. Hansen A/S (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary