Status:
COMPLETED
Efficacy of a Mix of Probiotics in Athletes Performance
Lead Sponsor:
Giuliani S.p.A
Collaborating Sponsors:
FitBiomics, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06093139
Start Date
November 29 2021
End Date
October 5 2022
Last Update
October 23 2023
Active Locations (1)
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1
Centro Sportivo Parma Football
Collecchio, Parma, Italy, 43044