The Effect of Probiotics on GI Symptoms

Gastrointestinal Symptoms Clinical Trial

— WHOMLF  

Official title:

The Effect of Probiotics on the Relationship Between the Gut Microbiota and Gastrointestinal Symptoms During Endurance Exercise'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959722
• Other study ID #: NL69974.081.19
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: May 2, 2020

Study information

• Verified date: September 2020
• Source: Hogeschool Leiden, University of Applied Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Gastrointestinal Symptoms

Intervention

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
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)

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Amsterdam	Amsterdam

Sponsors (6)

Lead Sponsor	Collaborator
Karlijn te Poele	MyMicroZoo, Universiteit Leiden, VU University of Amsterdam, Wageningen University and Research, Winclove Bio Industries BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temperature	Body temperature in degrees celcius during endurance exercise, calculated by core temperature and skin temperature	Before and after 14 weeks of supplementation
Other	Training diary	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)	During the 14 weeks supplementation period
Other	Profile of Mood States Questionnaire	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).	During the 14 weeks supplementation period
Primary	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
Primary	Performance maximal running maximal incremental exercise test	Maximum speed on a maximal rincremental exercise test	Before and after 14 weeks of supplementation
Primary	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	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.	Before and after 14 weeks of supplementation
Secondary	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	Before and after 14 weeks of supplementation