A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 1793… (NCT06205966) | Clinical Trial Compass
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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
Hungary142 participantsStarted 2023-12-21
Plain-language 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.
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)