Respiratory Tract InfectionsNCT04525040
ProbioKid as Prevention Among Kids With Frequent URTI
A study testing ProbioKid® and Pragmatic comparator in people with Respiratory Tract Infections, run by Lallemand Health Solutions.
Trial summary
This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- ProbioKid® and Pragmatic comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2016to 25 Jun 2017
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of children from 3 to 10 years,
- High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months).
- Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment).
Who cannot join
- Chronic pathological conditions.
About this study
Official title: Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases
This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.
Read the detailed description
The microbiota is very important for the development of the immune system in children. Lactic acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). Some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. For example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis, Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. In addition, the impact of a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.
- Conditions
- Respiratory Tract Infections
- Being tested
- ProbioKid®, Pragmatic comparator
- Keywords
- Frequent respiratory infection, pediatrics, probiotics
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioKid®Dietary supplement
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
Pragmatic comparatorOther
Standard of care as usual without a preventive intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks. Receives: Dietary Supplement: ProbioKid® |
| Pragmatic arm | Other | Children in this arm received standard of care as usual without a preventive intervention Receives: Other: Pragmatic comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and duration of URTI and related complications
Difference between group in the change [ follow-up - baseline]
Measured: 6 months prior to enrollment, and 6 months follow-up
Secondary outcomes (5)
Monthly incidence of URTI
Comparison of monthly incidence of URTI between the two groups during follow-up
Measured: 6 months after the intervention
Monthly number of visits to a specialized physician
Comparison of monthly number of visits to a specialized physician between the two groups during follow-up
Measured: 6 months after the intervention
Resistance index
Comparison of change in resistance index between the two groups
Measured: 6 months prior to enrollment and 6 months after intervention
Individual complication diagnosed (number of cases)
Comparison of the number of complications diagnosed between the two groups
Measured: 6 months prior to enrollment and 6 months after intervention
Number of antibiotics prescriptions
Comparison of the number of antibiotic courses prescribed between the two groups during follow-up
Measured: 6 months prior to enrollment and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start14 Sep 2016
- Primary completion25 Jun 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu V. Marushko, MD, Principal investigator, Bogomolets National Medical University (Kiev, Ukraine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525040
- Sponsor's protocol ID
- ProbioKid study
- Status last verified
- Jul 2020
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2020
- 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 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases
- ClinicalTrials.gov ID
- NCT04525040
- Acronym / sponsor ID
- ProbioKid study
- Conditions
- Respiratory Tract Infections
- Keywords
- Frequent respiratory infection, pediatrics, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 25 Aug 2020 (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.
This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.
Detailed description
The microbiota is very important for the development of the immune system in children. Lactic acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). Some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. For example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis, Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. In addition, the impact of a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: ProbioKid®Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks. |
| Pragmatic arm | Other | Other: Pragmatic comparatorChildren in this arm received standard of care as usual without a preventive intervention |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of children from 3 to 10 years,
- High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months).
- Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment).
Key exclusion criteria (1 listed)
- Chronic pathological conditions.
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 |
|---|---|---|
| ProbioKid®Probiokid formulation includes three probiotic strains and fructooligosaccharides. | Dietary supplement | Intervention arm |
| Pragmatic comparatorStandard of care as usual without a preventive intervention | Other | Pragmatic arm |
Primary outcome
Number and duration of URTI and related complications
Time frame: 6 months prior to enrollment, and 6 months follow-up
Difference between group in the change [ follow-up - baseline]
5 secondary outcomes
Monthly incidence of URTI
Time frame: 6 months after the intervention
Monthly number of visits to a specialized physician
Time frame: 6 months after the intervention
Resistance index
Time frame: 6 months prior to enrollment and 6 months after intervention
Individual complication diagnosed (number of cases)
Time frame: 6 months prior to enrollment and 6 months after intervention
Number of antibiotics prescriptions
Time frame: 6 months prior to enrollment and 6 months after intervention
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 25 Aug 2020.
- 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.
Yu V. Marushko, MD principal investigator
Bogomolets National Medical University (Kiev, Ukraine)
Questions about this trial
What is this clinical trial studying?
A study testing ProbioKid® and Pragmatic comparator in people with Respiratory Tract Infections, run by Lallemand Health Solutions.
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 3 inclusion and 1 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Number and duration of URTI and related complications (time frame: 6 months prior to enrollment, and 6 months follow-up). 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 25 Aug 2020.