Efficacy of a Mix of Probiotics in Athletes Performance

Study Overview
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Brief Summary
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Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance This study will intend: - To assess the tolerability and the efficacy of a food supplements into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.

Detailed Description
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The present study aimed at assessing the tolerability and the efficacy of a food supplements probiotics-based (L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules) into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.

Official Title
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Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Probiotic capsule
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female athletes18-45 years old (included). Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times. Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results. No participation in a similar study actually or during the previous 6 months. Subjects accepting to sign the Informed consent form. Exclusion Criteria: 1. Known sensitivity to any compound of the Investigational product. 2. Pregnant or breast feeding females or planning a pregnancy. 3. Serious intercurrent infection or other active disease up to three months prior to study entry. 4. History of concurrent malignancy. 5. History of significant alcohol or drug abuse. 6. Significant psycho-social or psychiatric disorders that may impair the subject's ability to meet the study requirements. 7. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study. 8. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules alongside additional potato starch as a filler). | Dietary Supplement: Probiotic capsule<br>* probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules<br>* Other names: L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules;|
| Placebo Comparator: Placebo<br>Placebo capsule (placebo consisted of the same capsules filled with potato starch) | Dietary Supplement: Placebo<br>* placebo consisted of the same capsules filled with potato starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of physical parameters: soreness | Change of Soreness (measured by a 5-point scale) between T1 and T2 | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | 
| Evaluation of physical parameters: fatigue | Change of Fatigue (measured by a 5-point scale) between T1 and T2 | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | 
| Evaluation of physical parameters: energy | Change of Energy (measured by a 5-point scale) between T1 and T2between T1 and T2 | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | 
| Evaluation of physical parameters:Sleep quality | Change of Sleep quality (evaluated by Sleep Quality Scale (SQS)) between T1 and T2between T1 and T2 | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | 
| Evaluation of physical parameters:Digestive symptoms | Change of the frequency of four individual digestive symptoms (abdominal pain/discomfort, bloating, flatulence/passage of gas and borborygmi/rumbling stomach) will be evaluated with five-point Likert scales that range from 0 (never) to 4 (every day of the week), between T1 and T2 | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | 
| Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing | 16S and metagenomic shotgun sequencing | at baseline (T0) | 
| Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing | 16S and metagenomic shotgun sequencing | at T1 (12 weeks with placebo) a | 
| Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing | 16S and metagenomic shotgun sequencing | at T1 (12 week with ACTIVE) | 
| Microbial dysbiosis ON URINE SAMPLES by mean of liquid chromatography- surface-activated chemical-ionization-electrospray ionization (LC/SASI-MS) and tandem mass spectrometry (MS/MS) | By mean of liquid chromatography bacteria that potentially could cause dysbiosis by analyzing the profile of urine's metabolites and combining the results in the SANIST platform which predicts the intestinal dysbiosis based on the antagonist and pathogen bacteria pharmacological activity | at baseline (T0), | 
| Microbial dysbiosis ON URINE SAMPLES by mean of liquid chromatography- surface-activated chemical-ionization-electrospray ionization (LC/SASI-MS) and tandem mass spectrometry (MS/MS) | By mean of liquid chromatography bacteria that potentially could cause dysbiosis by analyzing the profile of urine's metabolites and combining the results in the SANIST platform which predicts the intestinal dysbiosis based on the antagonist and pathogen bacteria pharmacological activity | at T1 (12 weeks with placebo) | 
| Microbial dysbiosis ON URINE SAMPLES by mean of liquid chromatography- surface-activated chemical-ionization-electrospray ionization (LC/SASI-MS) and tandem mass spectrometry (MS/MS) | By mean of liquid chromatography bacteria that potentially could cause dysbiosis by analyzing the profile of urine's metabolites and combining the results in the SANIST platform which predicts the intestinal dysbiosis based on the antagonist and pathogen bacteria pharmacological activity | T1 (12 week with ACTIVE) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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athletes, probiotics, performance