Infections, Respiratory TractPhase 2NCT01510938
Probiotics in Respiratory Tract Infections in Children
A Phase 2 study testing L. acidophilus DDS-1, B. lactis UABLA-12 in people with Infections, Respiratory Tract, run by Lviv National Medical University at 1 site in Ukraine.
Trial summary
The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- L. acidophilus DDS-1, B. lactis UABLA-12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteUkraine
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 2
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3-12 yrs
- At least one episode of respiratory tract infection in the previous epidemiological season
- Direct telephone access available
- Informed consent signed
Who cannot join
- Vaccination against the influenza
- Chronic adeno-tonsillar pathology
- Recurrent otitis
- Sinusitis
- Respiratory allergy
- Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome
Show all 12Show fewer
- Lactose intolerance
- Functional or organic constipation
- Down syndrome
- Congenital or acquired heart disease
- Cerebral palsy
- Any chronic hepatic, renal, metabolic, or immune system disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
- Conditions
- Infections, Respiratory Tract
- Being tested
- L. acidophilus DDS-1, B. lactis UABLA-12, Placebo
- Keywords
- Children, Respiratory Tract Infections, Prevention
- 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.
L. acidophilus DDS-1, B. lactis UABLA-12Dietary supplement
Also called DDS-Junior
1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
PlaceboDietary supplement
Also called Rice maltodextrin
1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. Receives: Dietary Supplement: Placebo |
| Probiotic | Experimental | powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide
1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. Receives: Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory tract infection episodes in a child
An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours
Measured: 1 month
Secondary outcomes (11)
Duration of respiratory tract infection
Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0
Measured: 21 days
Severity of respiratory tract infection
a product of daily CARIFS times the duration of the disease
Measured: 21 days
Complications of respiratory tract infections
Percent of otitis, sinusitis, bronchitis, pneumonia cases
Measured: 21 days
Antibiotic prescriptions
Percent
Measured: 21 days
Hospitalization rate
Number of hospitalizations
Measured: 21 days
Number of unscheduled doctor visits
Measured: 21 days
Number of days daycare/school missed
Measured: 21 days
Number of workdays missed by parents
Measured: 21 days
Time to resolution of individual CARIFS item
Days to the correspondent CARIFS item 0
Measured: 21
25% and 50% decrease in the CARIFS score
25% and 50% decrease in the CARIFS score
Measured: 21day
Percent and duration of the use of over-the-counter medications
Percent and duration of the use of over-the-counter medications
Measured: 21day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lviv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergei V. Gerasimov, MD, PhD, Lviv National Medical University
- Investigators
- Sergei V Gerasimov, M.D., Ph.D., Principal investigator, Lviv National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510938
- Sponsor's protocol ID
- SG-11009
- Status last verified
- Dec 2013
- First submitted
- 12 Jan 2012
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
- ClinicalTrials.gov ID
- NCT01510938
- Acronym / sponsor ID
- SG-11009
- Conditions
- Infections, Respiratory Tract
- Keywords
- Children, Respiratory Tract Infections, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Lviv National Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jan 2012 (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 purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
| Probiotic | Experimental | Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide 1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 3-12 yrs
- At least one episode of respiratory tract infection in the previous epidemiological season
- Direct telephone access available
- Informed consent signed
Key exclusion criteria (12 listed)
- Vaccination against the influenza
- Chronic adeno-tonsillar pathology
- Recurrent otitis
- Sinusitis
- Respiratory allergy
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 |
|---|---|---|
| L. acidophilus DDS-1, B. lactis UABLA-12Also: DDS-Junior1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. | Dietary supplement | Probiotic |
| PlaceboAlso: Rice maltodextrin1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. | Dietary supplement | Placebo |
Primary outcome
Incidence of respiratory tract infection episodes in a child
Time frame: 1 month
An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours
11 secondary outcomes
Duration of respiratory tract infection
Time frame: 21 days
Severity of respiratory tract infection
Time frame: 21 days
Complications of respiratory tract infections
Time frame: 21 days
Antibiotic prescriptions
Time frame: 21 days
Hospitalization rate
Time frame: 21 days
Number of unscheduled doctor visits
Time frame: 21 days
Number of days daycare/school missed
Time frame: 21 days
Number of workdays missed by parents
Time frame: 21 days
Time to resolution of individual CARIFS item
Time frame: 21
25% and 50% decrease in the CARIFS score
Time frame: 21day
Percent and duration of the use of over-the-counter medications
Time frame: 21day
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 30 Dec 2013.
Related trials for Infections, Respiratory Tract
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Sergei V Gerasimov, M.D., Ph.D. principal investigator
Lviv National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L. acidophilus DDS-1, B. lactis UABLA-12 in people with Infections, Respiratory Tract, run by Lviv National Medical University at 1 site in Ukraine.
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 4 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 30 Dec 2013. 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 Ukraine. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of respiratory tract infection episodes in a child (time frame: 1 month). 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 30 Dec 2013.