Prophylaxis of Gastrointestinal Infections With EcN

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital San Bartolome
• Collaborator: Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas

Criteria

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.