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

• Sponsor: Giuliani S.p.A (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06093139
• Collaborator: FitBiomics, Inc. (Industry)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Probiotic capsule; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance
• Actual Study Start Date: Nov 29, 2021
• Actual Primary Completion Date: Sep 20, 2022
• Actual Study Completion Date: Oct 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of physical parameters: soreness [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 [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 [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 [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 [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 [at baseline (T0)]

   16S and metagenomic shotgun sequencing

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

1. History of concurrent malignancy. 5. History of significant alcohol or drug abuse.

2. Significant psycho-social or psychiatric disorders that may impair the subject's ability to meet the study requirements.

3. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study.

4. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Sportivo Parma Football	Collecchio	Parma	Italy	43044

Sponsors and Collaborators

• Giuliani S.p.A
• FitBiomics, Inc.

Investigators

• Study Chair: DANIELA PINTO, Giuliani S.p.A

Study Documents (Full-Text)

• Informed Consent Form - Mar 11, 2020

More Information

Publications

None provided.

• Responsible Party: Giuliani S.p.A
• ClinicalTrials.gov Identifier: NCT06093139
• Other Study ID Numbers: GIU-PPA-0420
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giuliani S.p.A: athletes; probiotics; performance

Study Results

No Results Posted as of Oct 23, 2023