The effect of probiotic strains on intestinal permeability in well-trained adults
| ISRCTN | ISRCTN16686476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16686476 |
| Secondary identifying numbers | HND-GI-020 |
- Submission date
- 06/11/2015
- Registration date
- 06/11/2015
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Boege Alle 10-12
Hoersholm
2970
Denmark
Study information
| Study design | Randomized double-blind placebo-controlled parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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 |
| Study acronym | APRO |
| Study objectives | 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(s) | Regionala etikprövningsnämnden (Regional Ethical Committee) i Uppsala, 18/03/2015 , ref: Dnr 2015/077 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Completion date | 01/02/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 21/09/2015 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
701 82
Sweden
Sponsor information
Industry
Boege Alle 10-12
Hoersholm
2970
Denmark
"ROR" |
https://ror.org/01mv6bt66 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/05/2024 | 21/01/2025 | Yes | No |
Editorial Notes
21/01/2025: Publication reference added.
