The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses (NCT06079606) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses
Iceland200 participantsStarted 2022-09-10
Plain-language summary
This prospective cohort study will include 200 term children born in Landspitali University Hospital in Iceland. The cohort will be divided into four groups according to antibiotic exposure of which one is the control group. Children's immune responses to live oral rotavirus vaccine as well as conventional vaccinations given at three, five and 12 months old will be determined by measuring salivary and serologic responses. Responses will be compared between the four groups. Stool samples will also be collected from participants and the composition of the microbiome compared between the four groups.
Who can participate
Age range
6 Weeks
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:
* All term children born in Iceland from 2022-2023
Exclusion Criteria:
* Children born with emergency caesarean section
* Children born before 36 weeks of gestation
* Children diagnosed with primary or secondary immunodeficiency
* Use of immunosuppressive drugs at recruitment or during the follow up period (excluding inhaled corticosteroids and short term oral corticosteroids (\<3 consecutive days).
* Children with chromosomal, genetic or other congenital diseases or abnormalities
* Children with severe, chronic diseases or disabilities
* Informed consent not signed by parents
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.