Efficacy of a Mix of Probiotics in Athletes Performance

Healthy Clinical Trial

— GIU-PPA-0420  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06093139
• Other study ID #: GIU-PPA-0420
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: October 5, 2022

Study information

• Verified date: May 2023
• Source: Giuliani S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 5, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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
• Placebo
placebo consisted of the same capsules filled with potato starch

Locations

Country	Name	City	State
Italy	Centro Sportivo Parma Football	Collecchio	Parma

Sponsors (2)

Lead Sponsor	Collaborator
Giuliani S.p.A	FitBiomics, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing	16S and metagenomic shotgun sequencing	at baseline (T0)
Primary	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
Primary	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)
Primary	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),
Primary	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)
Primary	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)