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

Giuliani

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06093139

GIU-PPA-0420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

  2. 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.

  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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Probiotic capsule

Placebo

Placebo Comparator group

Description:

Placebo capsule (placebo consisted of the same capsules filled with potato starch)

Treatment:

Dietary Supplement: Placebo