Status:
UNKNOWN
Prophylaxis of Gastrointestinal Infections With EcN
Lead Sponsor:
Hospital San Bartolome
Collaborating Sponsors:
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
Conditions:
Infantile Diarrhea
Eligibility:
All Genders
3-12 years
Phase:
PHASE4
Brief 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 n...
Detailed Description
Newborns (treatment-group E) and infants at the age of 6 months (treatment-group L) shall be treated with 1 x 1 ml ECN-SUSPENSION for 10 days and observed until the age of 12 months.Treatment-group E ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01469273
Start Date
November 1 2011
End Date
December 1 2013
Last Update
November 10 2011
Active Locations (3)
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1
Centro de Salud Los Algarrobos
Piura, Piura, Peru
2
Centro de Salud Materno Inftantil de Castilla (CESAMICA)
Piura, Piura, Peru
3
Materno Infantil Santa Rosa
Piura, Piura, Peru