The Effect of Probiotics on GI Symptoms

NCT03959722 | Completed

• 1 other identifier: NL69974.081.19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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

Keywords

Endurance athletes; probiotics; endurance exercise

Outcome Measures

Primary Outcomes (3)

• Performance maximal running

  Distance in km on a 30 minute running time trial, preceded by two times 30 minutes submaximal exercise.

  Before and after 14 weeks of supplementation

• Performance maximal running maximal incremental exercise test

  Maximum speed on a maximal rincremental exercise test

  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)

  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.

  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.

  Before and after 14 weeks of supplementation

Other Outcomes (3)

• Temperature

  Before and after 14 weeks of supplementation

• Training diary

  During the 14 weeks supplementation period

• Profile of Mood States Questionnaire

  During the 14 weeks supplementation period

Study Arms (2)

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).

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)

Dietary Supplement: Placebo

Interventions

Ecologic® PERFORMANCE DIETARY_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)

Probiotics:Healthy male endurance athletes with GI symptoms

Placebo DIETARY_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)

Placebo: Healthy male endurance athletes with GI symptoms

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karlijn te Poele: lead
• VU University of Amsterdam: collaborator
• Wageningen University and Research: collaborator
• Universiteit Leiden: collaborator
• MyMicroZoo: collaborator
• Winclove Bio Industries BV: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, 1081BT, Netherlands

Location

Study Officials

• Karlijn te Poele, MSc

  Hogeschool Leiden, University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 22, 2019
• Study Start: November 19, 2019
• Primary Completion: May 2, 2020
• Study Completion: May 2, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)