HealthyGIU-PPA-0420NCT06093139
Efficacy of a Mix of Probiotics in Athletes Performance
A study testing Probiotic capsule in people with Healthy, run by Giuliani S.p.A at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 29 Nov 2021to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Probiotic capsule, Placebo
- Keywords
- athletes, probiotics, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic capsuleDietary supplement
Also called L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules
probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules
PlaceboDietary supplement
placebo consisted of the same capsules filled with potato starch
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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). Receives: Dietary Supplement: Probiotic capsule |
| Placebo | Placebo comparator | Placebo capsule (placebo consisted of the same capsules filled with potato starch) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of physical parameters: soreness
Change of Soreness (measured by a 5-point scale) between T1 and T2
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline (T0)
Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
16S and metagenomic shotgun sequencing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T1 (12 week with ACTIVE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start29 Nov 2021
- Primary completion20 Sep 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giuliani S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FitBiomics, Inc.
- Responsible party
- Sponsor
- Investigators
- DANIELA PINTO, Study chair, Giuliani S.p.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093139
- Sponsor's protocol ID
- GIU-PPA-0420
- Acronym
- GIU-PPA-0420
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance
- ClinicalTrials.gov ID
- NCT06093139
- Acronym / sponsor ID
- GIU-PPA-0420 / GIU-PPA-0420
- Conditions
- Healthy
- Keywords
- athletes, probiotics, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Giuliani S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- FitBiomics, Inc.
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Probiotic capsuleProbiotic 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). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule (placebo consisted of the same capsules filled with potato starch) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic capsuleAlso: L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsulesprobiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules | Dietary supplement | Active |
| Placeboplacebo consisted of the same capsules filled with potato starch | Dietary supplement | Placebo |
Primary outcome
Evaluation of physical parameters: soreness
Time frame: 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
Evaluation of physical parameters: fatigue
Time frame: 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
Evaluation of physical parameters: energy
Time frame: 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
Evaluation of physical parameters:Sleep quality
Time frame: 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
Evaluation of physical parameters:Digestive symptoms
Time frame: 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
Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
Time frame: at baseline (T0)
16S and metagenomic shotgun sequencing
Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
Time frame: at T1 (12 weeks with placebo) a
16S and metagenomic shotgun sequencing
Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
Time frame: at T1 (12 week with ACTIVE)
16S and metagenomic shotgun sequencing
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DANIELA PINTO study chair
Giuliani S.p.A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic capsule in people with Healthy, run by Giuliani S.p.A at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of physical parameters: soreness (time frame: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.