Virus Diseases in ChildrenNCT06205966
A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
A study testing BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938) in people with Virus Diseases in Children, run by Milosevits Gergely at 1 site in Hungary.
Trial summary
This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Virus Diseases in Children
- What is being tested?
- BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteHungary
- Study dates
- 21 Dec 2023to 30 Nov 2025
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
- Any gender
- Age from 4 years to 17 years
- Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
- Negative Strep test
Who cannot join
- Use of antibiotics or probiotics in the 10 days prior to study enrolment
- Use of a probiotic other than the test sample during the study
- Eight or more otitis media within 12 months
- Two or more bacterial sinusitis within 12 months
- Two or more pneumonia episodes within 12 months
- History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)
Show all 14Show fewer
- Chronic diarrhea
- Recurrent deep skin or organ abscesses
- Persistent superficial candidiasis
- Use of antibiotics for two months or more to treat respiratory infections within 12 months
- Gastroesophageal reflux
- Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
- Primary or secondary ciliary dyskinesia
- Congenital malformations of the respiratory tract
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Szent Miklós Szolgálat Kft.
Szigetszentmiklós, Pest County, 2310
Gergely Milosevits, M.D., PhD., +36308425722, drgergelymilosevits@gmail.com
Gergely Milosevits, M.D., PhD.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.
Read the detailed description
Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.
- Conditions
- Virus Diseases in Children
- Being tested
- BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)Dietary supplement
BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.
PlaceboOther
Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops. Receives: Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938) |
| Placebo | Placebo comparator | Placebo taken orally once in the morning and once in the evening, each time 5 drops. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
Measured: 10 days
Secondary outcomes (8)
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)
Measured: 10 days
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".
On a scale from 1 to 8.
Measured: 10 days
Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.
Measured: 10 days
Amount of NSAIDs used.
Measured: 10 days
Number of children receiving antibiotic treatment in each treatment group.
Measured: 10 days
Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".
Measured: 10 days
Number of unplanned medical visits (other than "Visit 1 and 2").
This outcome is defined as the total amount of medical office visits or emergency visits.
Measured: 10 days
Days of absences from day care center/school.
This outcome is defined as the total amount of days of absences from the day care centre during the study, due to the presence of episodes of URTI.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start21 Dec 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus Diseases in ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milosevits Gergely
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Milosevits Gergely, Szent Miklós Szolgálat Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205966
- Sponsor's protocol ID
- SzentMiklósSzolgálatKft.
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.
PubMed 33789556
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. 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 Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT06205966
- Acronym / sponsor ID
- SzentMiklósSzolgálatKft.
- Conditions
- Virus Diseases in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Milosevits GergelyUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 16 Jan 2024 (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 investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.
Detailed description
Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo taken orally once in the morning and once in the evening, each time 5 drops. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
- Any gender
- Age from 4 years to 17 years
- Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
- Negative Strep test
Key exclusion criteria (14 listed)
- Use of antibiotics or probiotics in the 10 days prior to study enrolment
- Use of a probiotic other than the test sample during the study
- Eight or more otitis media within 12 months
- Two or more bacterial sinusitis within 12 months
- Two or more pneumonia episodes within 12 months
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 |
|---|---|---|
| BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension. | Dietary supplement | Probiotics |
| PlaceboPlacebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri. | Other | Placebo |
Primary outcome
Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
Time frame: 10 days
8 secondary outcomes
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)
Time frame: 10 days
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".
Time frame: 10 days
Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.
Time frame: 10 days
Amount of NSAIDs used.
Time frame: 10 days
Number of children receiving antibiotic treatment in each treatment group.
Time frame: 10 days
Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".
Time frame: 10 days
Number of unplanned medical visits (other than "Visit 1 and 2").
Time frame: 10 days
Days of absences from day care center/school.
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 33789556Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938) in people with Virus Diseases in Children, run by Milosevits Gergely at 1 site in Hungary.
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 14 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: status not confirmed, as of the sponsor's last update on 16 Jan 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gergely Milosevits, MD, PhD (+36308425722, drgergelymilosevits@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06205966, which also lists 1 linked publication.
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 16 Jan 2024.