UnknownPhase 4

Prophylaxis of Gastrointestinal Infections With EcN

Peru198 participantsStarted 2011-11

Plain-language summary

This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.

Who can participate

Age range

3 Hours – 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: * Informed consent form signed by the patient's parents or legal guardians. * Term born infants. * Age \< 2 days * Gestational age from 38-42 weeks of gestation * Birth weight from 2500-3750 gr. * Normal delivery (eutocia) Exclusion criteria: * Simultaneous participation in another clinical study * Consumption of food supplements or medicines containing live micro-organisms or their metabolic products or components during the study * Other reasons which in the opinion of the investigator provide a reason against the inclusion of the patient in the study. * Autoimmune disease·Severe sepsis or severe systemic injury * Immunosuppressive treatment * Severe co-morbidities diseases of the: * Heart * Liver * Kidney * Genetic disease * Other serious associated diseases, which in the opinion of the investigator, cast a doubt on the implementation of the test according to the study protocol.

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

Number of diarrhea episodes

Timeframe: 12 months / first year of life

Trial details

NCT IDNCT01469273

SponsorHospital San Bartolome

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

Contact for this trial

Delfina Cetraro, MD

+51 1 4245217 finacetrarocardo@yahoo.es

View on ClinicalTrials.gov More Infantile Diarrhea trials