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| Sponsors and Collaborators: |
Colombian Neonatal Research Network Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) Vanderbilt University |
|---|---|
| Information provided by: | Colombian Neonatal Research Network |
| ClinicalTrials.gov Identifier: | NCT00727363 |
Purpose
This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe inflammatory disease of the bowel called necrotizing enterocolitis. The investigators propose that premature infants not given probiotics will colonize their gut with bad bacterias and develop infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Death Nosocomial Infection |
Dietary Supplement: Lactobacillus reuteri Dietary Supplement: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial |
| Estimated Enrollment: | 1110 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.
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Dietary Supplement: Placebo
5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital.
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2: Experimental
L reuteri DSM 17938
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Dietary Supplement: Lactobacillus reuteri
Lactobacillus reuteri DSM 17938 will be administered at a dose of ten to the eighth colony-forming units in 5 drops of a commercially available oil suspension once per day until discharge from the hospital.
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Show Detailed Description Eligibility| Ages Eligible for Study: | up to 48 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Juan M Lozano, MD, Msc | 0115713208320 ext 2801 | jmlozano@javeriana.edu.co |
| Contact: Maria X Rojas, RN, Msc | 0115713208320 ext 2811 | mxrojas@javeriana.edu.co |
| Colombia, Antioquia | |
| Hospital San Vicente de Paul | |
| Medellin, Antioquia, Colombia | |
| Colombia, Cundinamarca | |
| Hospital San Ignacio, Universidad Javeriana | |
| Bogota, Cundinamarca, Colombia | |
| Policlinico del Olaya | |
| Bogota, Cundinamarca, Colombia | |
| Colombia, Santander | |
| Hospital Universitario de Santander | |
| Bucaramanga, Santander, Colombia | |
| Clinica San Luis | |
| Bucaramanga, Santander, Colombia | |
| Colombia, Valle | |
| Fundacion Valle de Lilli | |
| Cali, Valle, Colombia | |
| Clinica los Farallones | |
| Cali, Valle, Colombia | |
| Clinica Los Remedios | |
| Cali, Valle, Colombia | |
| Study Director: | Mario A Rojas, MD, MPH | Vanderbilt University |
| Principal Investigator: | Juan M Lozano, MD, Msc | Universidad Javeriana |
More Information
| Responsible Party: | Universidad Javeriana ( Juan M Lozano MD, Msc. ) |
| Study ID Numbers: | CNRNProbiotics |
| Study First Received: | July 31, 2008 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00727363 |
| Health Authority: | Colombia: Institutional Review Board |
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probiotics lactobacillus reuteri preterm infants nosocomial infection necrotizing enterocolitis |
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Death Sepsis Necrotizing enterocolitis |
Enterocolitis, Necrotizing Enterocolitis Cross Infection |
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Infection |
