Gastrointestinal SymptomsWHOMLFNCT03959722
The Effect of Probiotics on GI Symptoms
A study testing Ecologic® PERFORMANCE in people with Gastrointestinal Symptoms, run by Karlijn te Poele at 1 site in Netherlands.
Trial summary
A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the occurrence and intensity of the gastrointestinal symptoms, on performance and on the composition and function of the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Ecologic® PERFORMANCE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Nov 2019to 2 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dutch nationality; maximal oxygen uptake (V ̇O_2max) ≥ 45 mL·kg-1·min-1 (based on an incremental exercise test you are considered trained);
- an average training frequency of at least three times per week;
- a low risk profile based on a health-history form (the form is attached to the participant information letter);
- occurrence of exercise-induced gastrointestinal symptoms.
Who cannot join
- smoking;
- a diagnosis of gastrointestinal disorders (e.g. Crohn's disease, celiac disease, diagnosed with irritable bowel syndrome);
- use of antidepressants in the 6 months prior to the start of the study;
- use of antibiotics, antivirals, antifungals, antiparasitic agents, prebiotics/probiotics supplements (foods are allowed) in the 6 months prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotics on the Relationship Between the Gut Microbiota and Gastrointestinal Symptoms During Endurance Exercise'
A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the occurrence and intensity of the gastrointestinal symptoms, on performance and on the composition and function of the gut microbiota. The duration of the supplementation period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized maximum exercise tests on a treadmill are performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the performance tests, the load is first submaximal for 1 hour, after which a time trial of 30 minutes will be performed. The measurements before and after the supplementation period are performed on individual days with at least 48 hours of relative rest in between. During the supplementation period, training diaries, a Profile of Mood States (POMS) questionnaire and a few questionnaires about dietary habits will be completed.
Read the detailed description
Rationale: Endurance exercise, such as running a marathon, is becoming increasingly popular. In addition to the many positive health effects of endurance exercise, it can also be accompanied by gastrointestinal symptoms. For example, around 30-90% of runners suffer from gastrointestinal symptoms during or in the hours after intensive/endurance running. The occurrence of gastrointestinal symptoms is probably due to the redistribution of blood volume, resulting in less blood supply to the digestive tract and a less functioning intestinal barrier. Because the intestinal barrier functions less, endotoxins can enter the bloodstream and cause inflammatory reactions. Running in the heat causes extra redistribution of the blood volume, because extra blood is needed for cooling of the body. It is known that the gut microbiota affect food digestion, but also the functioning of the cells that line the intestinal wall and the connections between these cells. It is possible that runners with gastrointestinal symptoms face a different composition of the gut microbiota and / or metabolites during endurance exercise compared to runners without any complaints, as a result of which the gut barrier functions less well and problems may occur. Many positive effects have been attributed to the use of probiotics in general. Amongst which, the reduction of gastrointestinal symptoms during endurance exercise, probably due to improvement in intestinal permeability. Hence, the main goal of our research project is to investigate whether the chance of and/or intensity of gastrointestinal symptoms during endurance exercise and the exercise performance can be influenced by probiotics supplementation in trained endurance athletes. This will be studied in relation to the composition of the gut microbiota and / or metabolites.
Objective:
Primary Objective:
Can the chance at and/or intensity of gastrointestinal symptoms during exercise be influenced by probiotics supplementation in trained endurance athletes who experience these symptoms and can performance be enhanced? Secondairy Objective: Can the composition and function of the gut microbiota of trained athletes that experience gastrointestinal symptoms during exercise be positively influenced by probiotics supplementation?
Study design: A double-blind randomized placebo-controlled trial will be performed to investigate the effect of 14 weeks probiotics supplementation with Ecologic® PERFORMANCE supplements. Standardized maximal incremental exercise tests will be performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the supplementation period training diaries, a POMS questionnaire and some questionnaires about food habits will be completed, a food diary and Food Frequency Questionnaire (FFQ).
Study population: Healthy male endurance athletes of Dutch nationality, 18-45 years old, who regularly experience gastrointestinal symptoms during exercise.
Intervention: Fourteen weeks of supplementation with Ecologic® PERFORMANCE probiotics supplements (or placebo).
Main study parameters/endpoints: Main study endpoints are differences in changes in the severity and occurrence of gastrointestinal symptoms and changes in exercise performance (total distance on a time trial and maximum speed during an incremental exercise test). Also changes in composition of the microbiota and differences in changes in the metabolites in the stool sample before and after the supplementation period in the experimental and control group will be studied.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Benefits will be the value of the test results and outcome measures of the microbiome analysis. Also the chance on a reduced risk of occurrence of gastrointestinal symptoms might be of value for potential participants. The risks for the participants are minor. Only participants that are healthy and endurance trained will be included. In the Human Performance Laboratory of the Faculty of Behavioural and Human Movement Sciences, performance tests in warm conditions are executed regularly and health risks related to the experimental protocol are minor for the participants since they are already well-trained and the exercise intensity will be relatively well-tolerated, since they are used to similar efforts. Probiotics supplements are freely available at the market, and the Ecologic® PERFORMANCE supplements are available in the web shop of Winclove B.V. The same supplement has been used before in the same dosage and no adverse effects were reported. Participants will fill in a food frequency questionnaire and questionnaire about gastrointestinal symptoms and hand in a stool sample before and after the supplementation period. They will be asked to maintain a training diary during the supplementation period and also fill in the POMS questionnaire weekly. The maximal incremental exercise test (2 times) consists of a warming-up followed by incremental increase in running velocity until voluntary exhaustion. The performance tests (3 times) consists of 60 minutes of submaximal running followed by a time trial of 30 minutes in which participants need to accomplish as much distance as possible.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Ecologic® PERFORMANCE, Placebo
- Keywords
- Endurance athletes, probiotics, endurance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic® PERFORMANCEDietary supplement
Ecologic® PERFORMANCE is a probiotic formulation consisting of different probiotic bacterial strains, namely:
Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Enterococcus faecium W54 Lactobacillus acidophilus W22 Lactobacillus brevis W63 Lactococcus lactis W58
Except for the bacterial strains, Ecologic® PERFORMANCE contains the following other ingredients:
- maize starch and maltodextrins
- fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
- vegetable protein
- mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)
PlaceboDietary supplement
The placebo contains no bacterial strains, but the following ingredients:
- maize starch and maltodextrins
- fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
- vegetable protein
- mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)
| Study group | Role | What they receive |
|---|---|---|
| Probiotics:Healthy male endurance athletes with GI symptoms | Experimental | 14 weeks of supplementation with a multispecies probiotics: Ecologic® PERFORMANCE ( 1*1010 CFU(Colony forming units)/daily dose, Winclove Probiotics B.V., Amsterdam). Receives: Dietary Supplement: Ecologic® PERFORMANCE |
| Placebo: Healthy male endurance athletes with GI symptoms | Placebo comparator | 14 weeks of supplementation with a placebo comparator (Winclove Probiotics B.V., Amsterdam) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance maximal running
Distance in km on a 30 minute running time trial, preceded by two times 30 minutes submaximal exercise.
Measured: Before and after 14 weeks of supplementation
Performance maximal running maximal incremental exercise test
Maximum speed on a maximal rincremental exercise test
Measured: Before and after 14 weeks of supplementation
Gastrointestinal symptoms
Severity (scale 1-10) of gastrointestinal symptoms during and directly after a running performance test. (1 = none and 10 = worst symptoms ever)
Measured: Before and after 14 weeks of supplementation
Secondary outcomes (2)
The influence of probiotics on the composition of the gut microbiota in trained endurance athletes that experience gastrointestinal symptoms.
Differences in changes in composition of the gut microbiota in the stool sample.
Measured: Before and after 14 weeks of supplementation
The influence of probiotics on the composition of the gut metabolites in trained endurance athletes that experience gastrointestinal symptoms.
Differences in changes in the gut metabolites in the stool sample
Measured: Before and after 14 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start19 Nov 2019
- Primary completion2 May 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karlijn te Poele
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Wageningen University and Research, Universiteit Leiden, MyMicroZoo, Winclove Bio Industries BV
- Responsible party
- Sponsor-investigator, Karlijn te Poele, Hogeschool Leiden, University of Applied Science
- Investigators
- Karlijn te Poele, MSc, Principal investigator, Hogeschool Leiden, University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959722
- Sponsor's protocol ID
- NL69974.081.19
- Acronym
- WHOMLF
- Status last verified
- Sep 2020
- First submitted
- 14 May 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on the Relationship Between the Gut Microbiota and Gastrointestinal Symptoms During Endurance Exercise'
- ClinicalTrials.gov ID
- NCT03959722
- Acronym / sponsor ID
- WHOMLF / NL69974.081.19
- Conditions
- Gastrointestinal Symptoms
- Keywords
- Endurance athletes, probiotics, endurance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karlijn te PoeleUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, Wageningen University and Research, Universiteit Leiden, MyMicroZoo, Winclove Bio Industries BV
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the occurrence and intensity of the gastrointestinal symptoms, on performance and on the composition and function of the gut microbiota. The duration of the supplementation period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized maximum exercise tests on a treadmill are performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the performance tests, the load is first submaximal for 1 hour, after which a time trial of 30 minutes will be performed. The measurements before and after the supplementation period are performed on individual days with at least 48 hours of relative rest in between. During the supplementation period, training diaries, a Profile of Mood States (POMS) questionnaire and a few questionnaires about dietary habits will be completed.
Detailed description
Rationale: Endurance exercise, such as running a marathon, is becoming increasingly popular. In addition to the many positive health effects of endurance exercise, it can also be accompanied by gastrointestinal symptoms. For example, around 30-90% of runners suffer from gastrointestinal symptoms during or in the hours after intensive/endurance running. The occurrence of gastrointestinal symptoms is probably due to the redistribution of blood volume, resulting in less blood supply to the digestive tract and a less functioning intestinal barrier. Because the intestinal barrier functions less, endotoxins can enter the bloodstream and cause inflammatory reactions. Running in the heat causes extra redistribution of the blood volume, because extra blood is needed for cooling of the body. It is known that the gut microbiota affect food digestion, but also the functioning of the cells that line the intestinal wall and the connections between these cells. It is possible that runners with gastrointestinal symptoms face a different composition of the gut microbiota and / or metabolites during endurance exercise compared to runners without any complaints, as a result of which the gut barrier functions less well and problems may occur. Many positive effects have been attributed to the use of probiotics in general. Amongst which, the reduction of gastrointestinal symptoms during endurance exercise, probably due to improvement in intestinal permeability. Hence, the main goal of our research project is to investigate whether the chance of and/or intensity of gastrointestinal symptoms during endurance exercise and the exercise performance can be influenced by probiotics supplementation in trained endurance athletes. This will be studied in relation to the composition of the gut microbiota and / or metabolites.
Objective:
Primary Objective:
Can the chance at and/or intensity of gastrointestinal symptoms during exercise be influenced by probiotics supplementation in trained endurance athletes who experience these symptoms and can performance be enhanced? Secondairy Objective: Can the composition and function of the gut microbiota of trained athletes that experience gastrointestinal symptoms during exercise be positively influenced by probiotics supplementation?
Study design: A double-blind randomized placebo-controlled trial will be performed to investigate the effect of 14 weeks probiotics supplementation with Ecologic® PERFORMANCE supplements. Standardized maximal incremental exercise tests will be performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the supplementation period training diaries, a POMS questionnaire and some questionnaires about food habits will be completed, a food diary and Food Frequency Questionnaire (FFQ).
Study population: Healthy male endurance athletes of Dutch nationality, 18-45 years old, who regularly experience gastrointestinal symptoms during exercise.
Intervention: Fourteen weeks of supplementation with Ecologic® PERFORMANCE probiotics supplements (or placebo).
Main study parameters/endpoints: Main study endpoints are differences in changes in the severity and occurrence of gastrointestinal symptoms and changes in exercise performance (total distance on a time trial and maximum speed during an incremental exercise test). Also changes in composition of the microbiota and differences in changes in the metabolites in the stool sample before and after the supplementation period in the experimental and control group will be studied.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Benefits will be the value of the test results and outcome measures of the microbiome analysis. Also the chance on a reduced risk of occurrence of gastrointestinal symptoms might be of value for potential participants. The risks for the participants are minor. Only participants that are healthy and endurance trained will be included. In the Human Performance Laboratory of the Faculty of Behavioural and Human Movement Sciences, performance tests in warm conditions are executed regularly and health risks related to the experimental protocol are minor for the participants since they are already well-trained and the exercise intensity will be relatively well-tolerated, since they are used to similar efforts. Probiotics supplements are freely available at the market, and the Ecologic® PERFORMANCE supplements are available in the web shop of Winclove B.V. The same supplement has been used before in the same dosage and no adverse effects were reported. Participants will fill in a food frequency questionnaire and questionnaire about gastrointestinal symptoms and hand in a stool sample before and after the supplementation period. They will be asked to maintain a training diary during the supplementation period and also fill in the POMS questionnaire weekly. The maximal incremental exercise test (2 times) consists of a warming-up followed by incremental increase in running velocity until voluntary exhaustion. The performance tests (3 times) consists of 60 minutes of submaximal running followed by a time trial of 30 minutes in which participants need to accomplish as much distance as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Probiotics:Healthy male endurance athletes with GI symptoms | Experimental | Dietary Supplement: Ecologic® PERFORMANCE14 weeks of supplementation with a multispecies probiotics: Ecologic® PERFORMANCE ( 1*1010 CFU(Colony forming units)/daily dose, Winclove Probiotics B.V., Amsterdam). |
| Placebo: Healthy male endurance athletes with GI symptoms | Placebo comparator | Dietary Supplement: Placebo14 weeks of supplementation with a placebo comparator (Winclove Probiotics B.V., Amsterdam) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Dutch nationality; maximal oxygen uptake (V ̇O_2max) ≥ 45 mL·kg-1·min-1 (based on an incremental exercise test you are considered trained);
- an average training frequency of at least three times per week;
- a low risk profile based on a health-history form (the form is attached to the participant information letter);
- occurrence of exercise-induced gastrointestinal symptoms.
Key exclusion criteria (4 listed)
- smoking;
- a diagnosis of gastrointestinal disorders (e.g. Crohn's disease, celiac disease, diagnosed with irritable bowel syndrome);
- use of antidepressants in the 6 months prior to the start of the study;
- use of antibiotics, antivirals, antifungals, antiparasitic agents, prebiotics/probiotics supplements (foods are allowed) in the 6 months prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologic® PERFORMANCEEcologic® PERFORMANCE is a probiotic formulation consisting of different probiotic bacterial strains, namely: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Enterococcus faecium W54 Lactobacillus acidophilus W22 Lactobacillus brevis W63 Lactococcus lactis W58 Except for the bacterial strains, Ecologic® PERFORMANCE contains the following other ingredients: * maize starch and maltodextrins * fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics) * vegetable protein * mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate) | Dietary supplement | Probiotics:Healthy male endurance athletes with GI symptoms |
| PlaceboThe placebo contains no bacterial strains, but the following ingredients: * maize starch and maltodextrins * fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics) * vegetable protein * mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate) | Dietary supplement | Placebo: Healthy male endurance athletes with GI symptoms |
Primary outcome
Performance maximal running
Time frame: Before and after 14 weeks of supplementation
Distance in km on a 30 minute running time trial, preceded by two times 30 minutes submaximal exercise.
Performance maximal running maximal incremental exercise test
Time frame: Before and after 14 weeks of supplementation
Maximum speed on a maximal rincremental exercise test
Gastrointestinal symptoms
Time frame: Before and after 14 weeks of supplementation
Severity (scale 1-10) of gastrointestinal symptoms during and directly after a running performance test. (1 = none and 10 = worst symptoms ever)
2 secondary outcomes
The influence of probiotics on the composition of the gut microbiota in trained endurance athletes that experience gastrointestinal symptoms.
Time frame: Before and after 14 weeks of supplementation
The influence of probiotics on the composition of the gut metabolites in trained endurance athletes that experience gastrointestinal symptoms.
Time frame: Before and after 14 weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlijn te Poele, MSc principal investigator
Hogeschool Leiden, University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologic® PERFORMANCE in people with Gastrointestinal Symptoms, run by Karlijn te Poele at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance maximal running (time frame: Before and after 14 weeks of supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.