The Effect of Probiotics on GI Symptoms (WHOMLF)
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|ClinicalTrials.gov Identifier: NCT03959722|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Symptoms||Dietary Supplement: Ecologic® PERFORMANCE Dietary Supplement: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Probiotics on the Relationship Between the Gut Microbiota and Gastrointestinal Symptoms During Endurance Exercise'|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Probiotics:Healthy male endurance athletes with GI symptoms
14 weeks of supplementation with a multispecies probiotics: Ecologic® PERFORMANCE ( 1*1010 CFU(Colony forming units)/daily dose, Winclove Probiotics B.V., Amsterdam).
Dietary Supplement: Ecologic® PERFORMANCE
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:
Placebo Comparator: Placebo: Healthy male endurance athletes with GI symptoms
14 weeks of supplementation with a placebo comparator (Winclove Probiotics B.V., Amsterdam)
Dietary Supplement: Placebo
The placebo contains no bacterial strains, but the following ingredients:
- The influence on the composition of the gut microbiota in trained endurance athletes that experience gastrointestinal symptoms. [ Time Frame: Before and after 14 weeks of supplementation ]Differences in changes in composition of the gut microbiota in the stool sample.
- The influence on the composition of the gut metabolites in trained endurance athletes that experience gastrointestinal symptoms. [ Time Frame: Before and after 14 weeks of supplementation ]Differences in changes in the gut metabolites in the stool sample
- 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.
- 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)
- Temperature [ Time Frame: Before and after 14 weeks of supplementation ]Body temperature in degrees celcius during endurance exercise, calculated by core temperature and skin temperature
- Training diary [ Time Frame: During the 14 weeks supplementation period ]Training load (in arbitrary units) calculated by modality, training volume (in km), training intensity (average HR) and a subjective measure of training intensity perception (RPE-scale 1=very, very light -10=maximum)
- Profile of Mood States Questionnaire [ Time Frame: During the 14 weeks supplementation period ]Summed outcome score of the weekly completed Profile Of Mood States questionnaire (with 32 questions with scale 0-4; 0=not at all - 4=extremely).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959722
|Contact: Karlijn te Poele, MSc||+31 (0)6 firstname.lastname@example.org|
|Contact: Marijke Mostert, Dr.||+31(0)6 email@example.com|
|Principal Investigator:||Karlijn te Poele, MSc||Hogeschool Leiden, University of Applied Sciences|