The Effect of Probiotics on GI Symptoms

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. 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.

Conditions

• Gastrointestinal Symptoms

Interventions

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)

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)

Sponsors & Collaborators

• VU University of Amsterdam

  collaborator OTHER

• Wageningen University and Research

  collaborator OTHER

• Universiteit Leiden

  collaborator OTHER

• MyMicroZoo

  collaborator UNKNOWN

• Winclove Bio Industries BV

  collaborator INDUSTRY

• Karlijn te Poele

  lead OTHER

Principal Investigators

• Karlijn te Poele, MSc · Hogeschool Leiden, University of Applied Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-19

Primary Completion

2020-05-02

Completion

2020-05-02

Countries

• Netherlands

Study Locations