Virus Diseases in ChildrenNCT07870824
A Study to Investigate the Effect of Probiotics (Limosilactobacillus Reuteri DSM 17938 and Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
A study testing Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633) in people with Virus Diseases in Children, run by Milosevits Gergely at 1 site in Hungary.
Trial summary
This study investigates the effect of Limosilactobacillus reuteri probiotic strains (DSM 17938 and DSM 33633) 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?
- Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteHungary
- Study dates
- 19 Oct 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
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 (Limosilactobacillus Reuteri DSM 17938 and Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
This study investigates the effect of Limosilactobacillus reuteri probiotic strains (DSM 17938 and DSM 33633) on symptoms of viral upper-respiratory tract infections in children.
- Conditions
- Virus Diseases in Children
- Being tested
- Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)Dietary supplement
Probiotics drops (L. reuteri DSM 17938 and L. reuteri DSM 33633) 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 (DSM 17938 and DSM 33633) taken orally once in the morning and once in the evening, each time 5 drops. Receives: Dietary Supplement: Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633) |
| 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.
Percent of observation periods with absence of symptoms in children 4 years to 17 years old with symptoms of viral upper-respiratory tract infection
Measured: 14 days
Secondary outcomes (9)
Duration of symptoms
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough) measured from baseline and to end of intervention (14 completed days of intervention).
Measured: 14 completed days of intervention
Severity of symptoms
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough), recorded in a "Symptom Diary" based on the clinically validated "Wisconsin Upper Respiratory Symptom Survey 11" (WURSS-11), but modified according to the study's characteristics.
Measured: 14 completed days of intervention
Duration of fever
Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day measured from baseline and to end of intervention (14 completed days of intervention).
Measured: 14 completed days of intervention
Amount of anti-pyretic and analgesic medication
Amount of anti-pyretic and analgesic medication, such as NSAIDs used from baseline and to end of intervention (14 completed days of intervention)
Measured: 14 completed days of intervention
Number of children receiving antibiotic treatment
Number of children receiving antibiotic treatment in each treatment group measured from baseline and to end of intervention (14 completed days of intervention).
Measured: 14 completed days of intervention
Total amount of days of antibiotic use
Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary" measured from baseline and to end of intervention (14 completed days of intervention).
Measured: 14 completed days of intervention
Number of unplanned medical visits
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 related to the infection, measured from baseline and to end of intervention (14 completed days of intervention)
Measured: 14 completed days of intervention
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 from baseline and to end of intervention (14 completed days of intervention).
Measured: 14 completed days of intervention
Safety of study product
This outcome includes registration of all adverse events, serious adverse events and monitoring of vital signs.
Measured: 14 completed days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start19 Oct 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 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
- NCT07870824
- Sponsor's protocol ID
- SzentMiklósSzolgálatKft
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. 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 (Limosilactobacillus Reuteri DSM 17938 and Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT07870824
- Acronym / sponsor ID
- SzentMiklósSzolgálatKft
- Conditions
- Virus Diseases in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Milosevits GergelyUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 13 Oct 2026 (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 Limosilactobacillus reuteri probiotic strains (DSM 17938 and DSM 33633) on symptoms of viral upper-respiratory tract infections in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)Study product containing L. reuteri (DSM 17938 and DSM 33633) 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 |
|---|---|---|
| Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)Probiotics drops (L. reuteri DSM 17938 and L. reuteri DSM 33633) 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
Percent of observation periods with absence of symptoms in children 4 years to 17 years old with symptoms of viral upper-respiratory tract infection
Time frame: 14 days
9 secondary outcomes
Duration of symptoms
Time frame: 14 completed days of intervention
Severity of symptoms
Time frame: 14 completed days of intervention
Duration of fever
Time frame: 14 completed days of intervention
Amount of anti-pyretic and analgesic medication
Time frame: 14 completed days of intervention
Number of children receiving antibiotic treatment
Time frame: 14 completed days of intervention
Total amount of days of antibiotic use
Time frame: 14 completed days of intervention
Number of unplanned medical visits
Time frame: 14 completed days of intervention
Days of absences from day care center/school.
Time frame: 14 completed days of intervention
Safety of study product
Time frame: 14 completed days of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633) 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gergely Milosevits (+36308425722, drgergelymilosevits@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of observation periods with absence of symptoms in children 4 years to 17 years old with symptoms of viral upper-respiratory tract infection (time frame: 14 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 NCT07870824, 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 22 Oct 2026.