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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
Sponsor:
Collaborators:
VU University of Amsterdam
Wageningen University and Research
Universiteit Leiden
MyMicroZoo
Winclove Bio Industries BV
Information provided by (Responsible Party):
Karlijn te Poele, Hogeschool Leiden, University of Applied Science

Brief Summary:
A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the composition and function of the gut microbiota and the occurrence and intensity of the gastrointestinal symptoms. The duration of the supplementation period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized maximum exercise tests 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms Dietary Supplement: Ecologic® PERFORMANCE Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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:

  • maize starch and maltodextrins
  • fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
  • vegetable protein
  • mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)

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:

  • maize starch and maltodextrins
  • fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
  • vegetable protein
  • mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)


Other Outcome Measures:
  1. 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

  2. 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)

  3. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Dutch nationality; maximal oxygen uptake (V ̇O_2max) ≥ 55 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Karlijn te Poele, MSc +31 (0)6 48134024 poele.te.k@hsleiden.nl
Contact: Marijke Mostert, Dr. +31(0)6 25709779 mostert.m@hsleiden.nl

Sponsors and Collaborators
Karlijn te Poele
VU University of Amsterdam
Wageningen University and Research
Universiteit Leiden
MyMicroZoo
Winclove Bio Industries BV
Investigators
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Principal Investigator: Karlijn te Poele, MSc Hogeschool Leiden, University of Applied Sciences

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Responsible Party: Karlijn te Poele, MSc., Hogeschool Leiden, University of Applied Science
ClinicalTrials.gov Identifier: NCT03959722     History of Changes
Other Study ID Numbers: NL69974.081.19
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karlijn te Poele, Hogeschool Leiden, University of Applied Science:
Endurance athletes
probiotics
endurance exercise