Infantile Diarrhea Clinical Trial
— PIURAOfficial title:
Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle
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.
Status | Not yet recruiting |
Enrollment | 198 |
Est. completion date | December 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 12 Months |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Peru | Centro de Salud Los Algarrobos | Piura | |
Peru | Centro de Salud Materno Inftantil de Castilla (CESAMICA) | Piura | |
Peru | Materno Infantil Santa Rosa | Piura |
Lead Sponsor | Collaborator |
---|---|
Hospital San Bartolome | Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas |
Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of diarrhea episodes | To show superiority of a prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea, compared to an untreated control group | 12 months / first year of life | Yes |
Secondary | Number of days with diarrhea | To show prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea within the first 12 months of life compared to an untreated control group. | 12 months / first year of life | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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