Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants (NCT06161285) | Clinical Trial Compass
RecruitingNot Applicable
Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
France120 participantsStarted 2024-12-06
Plain-language summary
Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.
Who can participate
Age range
1 Day – 12 Months
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:
* Infants \<12 months
* With bronchiolitis during RSV epidemic season
* No chronic illness
* No bronchiolitis medical history
* Signed consent from parents or legal guardians
Exclusion Criteria:
* Chronic respiratory illness
* Medical history of bronchiolitis or newborn asthma
* Treatment with immunosuppressants
* Patient with no social security affiliation
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.