CompletedNot Applicable

Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Slovenia98 participantsStarted 2016-11

Plain-language summary

The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.

Who can participate

Age range

21 Days

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: * term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection Exclusion Criteria: * gestational age under 37 weeks * birth weight less than 2500 grams * congenital malformations/syndromes * perinatal hypoxia * who had received probiotics before the randomization * have had cow's milk protein allergy diagnosed during the study * patient who will be treated with antibiotic for less than 5 days

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

Functional gastrointestinal dysfunction

Timeframe: At 6 months of age

Composition of gut microbiota in infants - 1

Timeframe: At 6 weeks after intervention

Infants crying duration time

Timeframe: At 6 months of age

Composition of gut microbiota in infants - 2

Timeframe: At one year of age

Trial details

NCT IDNCT02865564

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

View on ClinicalTrials.gov More Gastrointestinal Diseases trials