Acute Upper Respiratory Tract Infections (Common Cold)NCT02640352
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
A study testing Probi Defendum in people with Acute Upper Respiratory Tract Infections (Common Cold), run by Probi AB at 1 site in Italy.
Trial summary
The aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Upper Respiratory Tract Infections (Common Cold)
- What is being tested?
- Probi Defendum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Sep 2018
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents / legal guardians signed written informed consent to participate in the study.
- Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment.
- Children attending day care center or school.
- No consumption of commercial products containing probiotics during the whole study period.
- Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day).
- Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study.
- Parents' / legal guardians' consent to the study and willing to comply with all its procedures.
Who cannot join
- Children presenting one or more of the following criteria will not be eligible to enter the study.
- Flu vaccine administration within the last 3 months prior to enrollment.
- Use of antibiotics within the last 30 days prior to enrollment.
- Acute infection or fever at enrollment.
- Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study.
- Any kind of immunodeficiency or allergy (including known food allergy).
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- Subjects with known hypersensitivity or allergy to any component of the study products.
- Significant illness within the 2 weeks prior to the enrollment or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
The aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. The probiotic bacteria used are Lactobacillus plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9 CFU/tablet and day and will be consumed for a period of 12 weeks.
- Being tested
- Probi Defendum, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probi DefendumDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probi Defendum | Active comparator | Dietary supplement (tablet) with probiotics Receives: Dietary Supplement: Probi Defendum |
| Placebo | Placebo comparator | Dietary supplement (tablet) without probiotics Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of acute upper respiratory tract infections (common cold), by means of the validated Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire (total sum score), during 12 weeks of daily intake of either Probi Defendum® or placebo.
Measured: 12 weeks
Secondary outcomes (3)
Number of common cold episodes
Measured: 12 weeks
Duration of common cold episodes
Measured: 12 weeks
Incidence of common cold episodes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract Infections (Common Cold)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640352
- Sponsor's protocol ID
- PROIMKID_15
- Status last verified
- Oct 2018
- First submitted
- 22 Dec 2015
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
- ClinicalTrials.gov ID
- NCT02640352
- Acronym / sponsor ID
- PROIMKID_15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 28 Dec 2015 (estimated)
- 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 aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. The probiotic bacteria used are Lactobacillus plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9 CFU/tablet and day and will be consumed for a period of 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probi Defendum | Active comparator | Dietary Supplement: Probi DefendumDietary supplement (tablet) with probiotics |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement (tablet) without probiotics |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents / legal guardians signed written informed consent to participate in the study.
- Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment.
- Children attending day care center or school.
- No consumption of commercial products containing probiotics during the whole study period.
- Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day).
Key exclusion criteria (9 listed)
- Children presenting one or more of the following criteria will not be eligible to enter the study.
- Flu vaccine administration within the last 3 months prior to enrollment.
- Use of antibiotics within the last 30 days prior to enrollment.
- Acute infection or fever at enrollment.
- Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of 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 |
|---|---|---|
| Probi Defendum | Dietary supplement | Probi Defendum |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Severity of acute upper respiratory tract infections (common cold), by means of the validated Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire (total sum score), during 12 weeks of daily intake of either Probi Defendum® or placebo.
Time frame: 12 weeks
3 secondary outcomes
Number of common cold episodes
Time frame: 12 weeks
Duration of common cold episodes
Time frame: 12 weeks
Incidence of common cold episodes
Time frame: 12 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 17 Oct 2018.
- 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 Probi Defendum in people with Acute Upper Respiratory Tract Infections (Common Cold), run by Probi AB 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 7 inclusion and 9 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 17 Oct 2018. 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?
Severity of acute upper respiratory tract infections (common cold), by means of the validated Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire (total sum score), during 12 weeks of daily intake of either Probi Defendum® or placebo. (time frame: 12 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 17 Oct 2018.