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RecruitingNCT07870824Updated Oct 22, 2026

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

An interventional study of Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633) and Placebo in Virus Diseases in Children, sponsored by Milosevits Gergely. Recruiting at 1 site in Hungary. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Milosevits Gergely · Not applicable, Interventional, and Supportive care

Updated Oct 22, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
4 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Virus Diseases in Children
03

In context

Lead sponsor

Milosevits Gergely is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
  • Negative Strep test

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
194 participants (estimated)

Study arms

  • Active comparator
    Probiotics

    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.

    Dietary Supplement: Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)

  • Placebo comparator
    Placebo

    Placebo taken orally once in the morning and once in the evening, each time 5 drops.

    Other: Placebo

Interventions

  • Dietary supplementProbiotics (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.

  • OtherPlacebo

    Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

    Time frame: 14 completed days of intervention

  2. 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.

    Time frame: 14 completed days of intervention

  3. 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).

    Time frame: 14 completed days of intervention

  4. 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)

    Time frame: 14 completed days of intervention

  5. 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).

    Time frame: 14 completed days of intervention

  6. 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).

    Time frame: 14 completed days of intervention

  7. 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)

    Time frame: 14 completed days of intervention

  8. 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).

    Time frame: 14 completed days of intervention

  9. Safety of study product

    This outcome includes registration of all adverse events, serious adverse events and monitoring of vital signs.

    Time frame: 14 completed days of intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Mar 2028, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartActual
Oct 19, 2026
Primary completionEst.
Mar 30, 2028
CompletionEst.
Mar 30, 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
Szent Miklós Szolgálat Kft. is now Recruiting
Oct 22, 2026
Start date
Oct 12, 2026→Oct 19, 2026 (actual)
Oct 22, 2026
Title
A Study to Investigate the Effect of Probiotics (L.Limosilactobacillus Reuteri DSM 17938 and L.Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
Oct 22, 2026
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    Szent Miklós Szolgálat Kft. is now Recruiting
    Start date Oct 12, 2026→Oct 19, 2026 (now actual)
    Title A Study to Investigate the Effect of Probiotics (L.Limosilactobacillus Reuteri DSM 17938 and L.Limosilactobacillus Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children
    + 1 other change: description
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870824
Lead sponsor
Milosevits Gergely
Responsible party
Milosevits Gergely (Principal Investigator, Szent Miklós Szolgálat Kft.) — Sponsor-investigator
First posted
Oct 13, 2026
Start date
Oct 19, 2026
Primary completion
Mar 30, 2028 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Gergely Milosevits
Contact
drgergelymilosevits@gmail.com
+36308425722

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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