Efficacy of a Mix of Probiotics in Athletes Performance (GIU-PPA-0420)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotic capsule; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma
    • Collecchio, Parma, Italy, 43044
      • Centro Sportivo Parma Football

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 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; 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 Comparator: Placebo; Placebo capsule (placebo consisted of the same capsules filled with potato starch)	Dietary supplement: Placebo; placebo consisted of the same capsules filled with potato starch

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Giuliani S.p.A
• Collaborators: FitBiomics, Inc.
• Investigators: Study Chair: DANIELA PINTO, Giuliani S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; athletes; performance
• Other Study ID Numbers: GIU-PPA-0420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No