Clinical trial NCT06093139: Efficacy of a Mix of Probiotics in Athletes Performance
Official title: Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: athletes
probiotics
performance
Lead sponsor: Giuliani S.p.A
Sponsor class: INDUSTRY
Collaborators: name: FitBiomics, Inc.
First posted: 2023-10-23
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and Female athletes18-45 years old (included).
2. Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times.
3. Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results.
4. No participation in a similar study actually or during the previous 6 months.
5. 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.

Primary outcomes:
measure: Evaluation of physical parameters: soreness
timeFrame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
measure: Evaluation of physical parameters: fatigue
timeFrame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
measure: Evaluation of physical parameters: energy
timeFrame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
measure: Evaluation of physical parameters:Sleep quality
timeFrame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
measure: Evaluation of physical parameters:Digestive symptoms
timeFrame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
measure: Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
timeFrame: at baseline (T0)
measure: Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
timeFrame: at T1 (12 weeks with placebo) a
measure: Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
timeFrame: at T1 (12 week with ACTIVE)
measure: 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)
timeFrame: at baseline (T0),
measure: 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)
timeFrame: at T1 (12 weeks with placebo)
measure: 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)
timeFrame: T1 (12 week with ACTIVE)
Secondary outcomes:
Other outcomes:
Locations:
city: Collecchio
country: Italy
facility: Centro Sportivo Parma Football
state: Parma
Study officials:
affiliation: Giuliani S.p.A
name: DANIELA PINTO
role: STUDY_CHAIR
References: