- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01249911
Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants
Efficacy & Cost-Effectiveness of Lactobacillus Reuteri DSM 17938 Administration to Prevent the Risk of Respiratory or Gastrointestinal Infections in Child Day Care Centers: A Randomized, Double Blind, Placebo Control Trial (RDDCT).
Randomized, doble blind, clinical, controlled trial aimed to investigate the role of Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract infections in mexican children who attend day care centers.
Primary Outcome: The primary outcome will be "days with diarrhoea". Secondary Outcomes: a) Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c) Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct and Indirect costs.
Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260 healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108 colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks, follow up for other additionally 12 weeks of observation. Days with respiratory tract infections (RTI); days of absences from day care centre; days of antibiotic use; days of medical office visits or emergency visits; and direct and Indirect costs will be compare between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness analysis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy infants
- Born at term (≥36 weeks of gestation)
- Any gender
- 6 to 36 months old
- Same socioeconomic background
- Written informed consent from parents or legal guardians
Exclusion Criteria:
- Birth weight <2500 g
- Congenital anomalies
- Chronic diseases
- Failure to thrive
- Allergy or atopic disease
- Recent (within the preceding 4 weeks) exposure to probiotics, prebiotics, or antibiotics.
- Concurrent participation in other clinical trials
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Lreuteri
Group of 130 infants allocated to receive L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle.
In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together with pharmaceutical grade silicon dioxide to give the product the correct rheological properties.
|
L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle.
In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together with pharmaceutical grade silicon dioxide to give the product the correct rheological properties.
|
Comparateur placebo: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present
|
Le placebo consiste en une formulation identique sauf que le L. reuteri n'est pas présent
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
days with diarrhoea
Délai: January 2011 to June 2011
|
Diarrhoea is defined as 3 or more loose or watery stools within 24 hours with or without vomiting.
Days with diarrhoea is defined as the total amount of days with diarrhoea since the beginning of the study products administration until the last visit occurs.
If liquid or loose stools is present a notification shall be made to the principal investigator.
|
January 2011 to June 2011
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Days with respiratory tract infections (RTI)
Délai: January 2011 to June 2011
|
Total amount of days with any RTI (common cold, rhinitis, acute rhinosinusitis, otitis, pharyngitis, tonsillitis, laryngitis, traqueítis, bronchiolitis, pneumonia), reported since the beginning of the study products administration until the last visit occurs
|
January 2011 to June 2011
|
Days of absences from day care centre
Délai: January 2011 to June 2011
|
Total amount of days of absences from the day care centre during the study, secondary to the presence of a gastrointestinal episode or RTI, reported since the beginning of the study products administration until the last visit occurs
|
January 2011 to June 2011
|
Days of antibiotic use
Délai: January 2011 to June 2011
|
Total amount of days of antibiotic use during the study, secondary to the presence of a gastrointestinal episode or RTI, reported since the beginning of the study products administration until the last visit occur
|
January 2011 to June 2011
|
Days of medical office visits or emergency visits
Délai: January 2011 to June 2011
|
Total amount of medical office visits or emergency visits during the study, secondary to the presence of a gastrointestinal episode or RTI, reported since the beginning of the study products administration until the last visit occurs.
|
January 2011 to June 2011
|
Direct and Indirect costs
Délai: January 2011 to June 2011
|
Total amount of money spent by hospital or parents (or guardians) during the study and secondary to the presence of a gastrointestinal episode or RTI, reported since the beginning of the study products administration until the last visit occur
|
January 2011 to June 2011
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pedro Gutierrez-Castrellon, MD, MSc, DSc, National Insitute of Pediatrics, Mexico
- Directeur d'études: Gabriel Lopez Velazquez, PhD, National Institute of Pediatrics, Mexico
Publications et liens utiles
Publications générales
- Weizman Z, Asli G, Alsheikh A. Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan;115(1):5-9. doi: 10.1542/peds.2004-1815.
- Rosenfeldt V, Benfeldt E, Valerius NH, Paerregaard A, Michaelsen KF. Effect of probiotics on gastrointestinal symptoms and small intestinal permeability in children with atopic dermatitis. J Pediatr. 2004 Nov;145(5):612-6. doi: 10.1016/j.jpeds.2004.06.068.
- Savino F, Cordisco L, Tarasco V, Palumeri E, Calabrese R, Oggero R, Roos S, Matteuzzi D. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010 Sep;126(3):e526-33. doi: 10.1542/peds.2010-0433. Epub 2010 Aug 16.
- Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.
- Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. doi: 10.1016/j.jpeds.2010.04.066. Epub 2010 Jun 12.
- Shornikova AV, Casas IA, Isolauri E, Mykkanen H, Vesikari T. Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children. J Pediatr Gastroenterol Nutr. 1997 Apr;24(4):399-404. doi: 10.1097/00005176-199704000-00008.
- Shornikova AV, Casas IA, Mykkanen H, Salo E, Vesikari T. Bacteriotherapy with Lactobacillus reuteri in rotavirus gastroenteritis. Pediatr Infect Dis J. 1997 Dec;16(12):1103-7. doi: 10.1097/00006454-199712000-00002.
- Abrahamsson TR, Jakobsson T, Bottcher MF, Fredrikson M, Jenmalm MC, Bjorksten B, Oldaeus G. Probiotics in prevention of IgE-associated eczema: a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 May;119(5):1174-80. doi: 10.1016/j.jaci.2007.01.007. Epub 2007 Mar 8.
- Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Moller PL, Pedersen P, Tvede M, Weyrehter H, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in young children hospitalized with acute diarrhea. Pediatr Infect Dis J. 2002 May;21(5):411-6. doi: 10.1097/00006454-200205000-00012.
- Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. Effects of probiotic and prebiotic on gastrointestinal motility in newborns. J Physiol Pharmacol. 2009 Dec;60 Suppl 6:27-31.
- Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Bjorksten B. Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. J Pediatr Gastroenterol Nutr. 2009 Sep;49(3):349-54. doi: 10.1097/MPG.0b013e31818f091b.
- Bottcher MF, Abrahamsson TR, Fredriksson M, Jakobsson T, Bjorksten B. Low breast milk TGF-beta2 is induced by Lactobacillus reuteri supplementation and associates with reduced risk of sensitization during infancy. Pediatr Allergy Immunol. 2008 Sep;19(6):497-504. doi: 10.1111/j.1399-3038.2007.00687.x. Epub 2008 Jan 22.
- Fass RJ, Plouffe JF, Russell JA. Intravenous/oral ciprofloxacin versus ceftazidime in the treatment of serious infections. Am J Med. 1989 Nov 30;87(5A):164S-168S. doi: 10.1016/0002-9343(89)90050-8.
- Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Moller PL, Tvede M, Weyrehter H, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains on acute diarrhea in a cohort of nonhospitalized children attending day-care centers. Pediatr Infect Dis J. 2002 May;21(5):417-9. doi: 10.1097/00006454-200205000-00013.
- Gutierrez-Castrellon P, Lopez-Velazquez G, Diaz-Garcia L, Jimenez-Gutierrez C, Mancilla-Ramirez J, Estevez-Jimenez J, Parra M. Diarrhea in preschool children and Lactobacillus reuteri: a randomized controlled trial. Pediatrics. 2014 Apr;133(4):e904-9. doi: 10.1542/peds.2013-0652. Epub 2014 Mar 17.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LreuteriMexico
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