Cold SymptomNCT05656729
Effect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients with an History of Upper Airways Infection
A study testing DefensePlus in people with Cold Symptom, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Symptom
- What is being tested?
- DefensePlus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 22 Dec 2022to 30 Jul 2024
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- people who:
- are willing and capable of joining the study
- are willing of not varying their routine (lifestyle, physical activity..) during the study
- are willing of not varying their diet during the study
- are willing of using only the testing product during the study
- are willing of not using products that may interfere with the testing product
- have not recently joined similar studies
- have signed informed consent
Who cannot join
- subjects:
- not filling the inclusion criteria
- with suspected or confirmed sensibility to one or more product component
- with chronic diseases (cardiovascular congenital diseases, hepatic diseases, renal disease, immunodeficiency)
- undergoing antibiotic/pharmacological treatment
- with other concomitant disease (infective, respiratory, gastrointestinal, immune)
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- who underwent an immunomodulating treatment in the past 4 weeks
- who underwent an immunosuppressant therapy in the past 3 months
- with severe disease ongoing
- who abuse of alcohol and/or drugs
- who are considered not eligible by the investigator
- not able to communicate due to language barriers, mental issues or cerebral functioning impairment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Ferrara, 44124
About this study
Official title: Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli, Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Comuni Sintomi Da Raffreddamento E La Risposta Immunitaria in Adulti Sani - ImmunoCold 2021
The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response
Read the detailed description
Adult subjects (age 18-44) with a history of upper airways infection, will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 12 weeks. After that, a 6 weeks follow-up. The answers at: Common Cold Questionnarie (CCQ), Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21) and quality of life score (SF-36) will be compared in the two groups. In addition, serological markers (blood count, lymphocyte subpopulation (B, T, T4, T8, NK), IFN-γ and IL-10 levels) will be evaluated over a 18 week period.
- Conditions
- Cold Symptom
- Being tested
- DefensePlus, Placebo
- Keywords
- cold, cold symptoms, probiotics
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefensePlusDietary supplement
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
PlaceboDietary supplement
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 8-week daily administration Receives: Dietary Supplement: Placebo |
| Multistrain probiotic | Active comparator | Dietary Supplement: Multistrain Probiotic 12-week daily administration Receives: Dietary Supplement: DefensePlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold symptoms evaluation
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
Measured: 18 weeks
Secondary outcomes (3)
Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms
Measured: 18 weeks
Change of Short Form Health Survey 36 (SF-36)
Higher score on Short Form Health Survey 36 (SF-36) questionnaire will be considered as an improvement of life quality. Highest score: 147, Lowest 0. Higher scores indicate better perception of one's health
Measured: 18 weeks
Inflammatory status
A reduction of inflammatory markers (INF-y, IL-10, and lymphocite B, T, T4, T8, NK) will be considered as an improvement of inflammatory status
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start22 Dec 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold SymptomStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Caio, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656729
- Sponsor's protocol ID
- ImmunoCold 2021
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2022
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli, Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Comuni Sintomi Da Raffreddamento E La Risposta Immunitaria in Adulti Sani - ImmunoCold 2021
- ClinicalTrials.gov ID
- NCT05656729
- Acronym / sponsor ID
- ImmunoCold 2021
- Conditions
- Cold Symptom
- Keywords
- cold, cold symptoms, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 Dec 2022 (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.
The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response
Detailed description
Adult subjects (age 18-44) with a history of upper airways infection, will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 12 weeks. After that, a 6 weeks follow-up. The answers at: Common Cold Questionnarie (CCQ), Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21) and quality of life score (SF-36) will be compared in the two groups. In addition, serological markers (blood count, lymphocyte subpopulation (B, T, T4, T8, NK), IFN-γ and IL-10 levels) will be evaluated over a 18 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 8-week daily administration |
| Multistrain probiotic | Active comparator | Dietary Supplement: DefensePlusDietary Supplement: Multistrain Probiotic 12-week daily administration |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- are willing and capable of joining the study
- are willing of not varying their routine (lifestyle, physical activity..) during the study
- are willing of not varying their diet during the study
- are willing of using only the testing product during the study
- are willing of not using products that may interfere with the testing product
Key exclusion criteria (12 listed)
- not filling the inclusion criteria
- with suspected or confirmed sensibility to one or more product component
- with chronic diseases (cardiovascular congenital diseases, hepatic diseases, renal disease, immunodeficiency)
- undergoing antibiotic/pharmacological treatment
- with other concomitant disease (infective, respiratory, gastrointestinal, immune)
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 |
|---|---|---|
| DefensePlusMultistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide | Dietary supplement | Multistrain probiotic |
| PlaceboMaltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide | Dietary supplement | Placebo |
Primary outcome
Cold symptoms evaluation
Time frame: 18 weeks
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
3 secondary outcomes
Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
Time frame: 18 weeks
Change of Short Form Health Survey 36 (SF-36)
Time frame: 18 weeks
Inflammatory status
Time frame: 18 weeks
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 6 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DefensePlus in people with Cold Symptom, run by Università degli Studi di Ferrara 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 8 inclusion and 12 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 6 Dec 2024. 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?
Cold symptoms evaluation (time frame: 18 weeks). 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 6 Dec 2024.