Condition category
Digestive System
Date applied
06/11/2015
Date assigned
06/11/2015
Last edited
06/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Adam Baker

ORCID ID

Contact details

Boege Alle 10-12
Hoersholm
2970
Denmark

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

Sponsor information

Organisation

Chr. Hansen A/S (Denmark)

Sponsor details

Boege Alle 10-12
Hoersholm
2970
Denmark

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes