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Completed

NCT Number: NCT06093139

Efficacy of a Mix of Probiotics in Athletes Performance

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centro Sportivo Parma Football

Collecchio, Parma, 43044, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study.
  • Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.

Treatment and study plan

Probiotic capsule

Dietary Supplement

probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules

Other names: L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules

Placebo

Dietary Supplement

placebo consisted of the same capsules filled with potato starch

Primary outcomes

  1. Evaluation of physical parameters: soreness

    Time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

    Change of Soreness (measured by a 5-point scale) between T1 and T2

  2. Evaluation of physical parameters: fatigue

    Time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

    Change of Fatigue (measured by a 5-point scale) between T1 and T2

  3. Evaluation of physical parameters: energy

    Time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

    Change of Energy (measured by a 5-point scale) between T1 and T2between T1 and T2

  4. Evaluation of physical parameters:Sleep quality

    Time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

    Change of Sleep quality (evaluated by Sleep Quality Scale (SQS)) between T1 and T2between T1 and T2

  5. Evaluation of physical parameters:Digestive symptoms

    Time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

    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

  6. Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

    Time frame: at baseline (T0)

    16S and metagenomic shotgun sequencing

  7. Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

    Time frame: at T1 (12 weeks with placebo) a

    16S and metagenomic shotgun sequencing

  8. Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

    Time frame: at T1 (12 week with ACTIVE)

    16S and metagenomic shotgun sequencing

  9. 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)

    Time frame: at baseline (T0),

    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

  10. 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)

    Time frame: at T1 (12 weeks with placebo)

    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

  11. 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)

    Time frame: T1 (12 week with ACTIVE)

    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

Sponsors and collaborators

Lead sponsor

Giuliani S.p.A

Industry

Collaborators

  • FitBiomics, Inc.

Registry information

Official study title

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

Acronym: GIU-PPA-0420

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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