Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy Infants	Dietary Supplement: Lreuteri Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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).

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Diarrhea

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by National Institute of Pediatrics, Mexico:

Primary Outcome Measures:

days with diarrhoea [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Days with respiratory tract infections (RTI) [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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
Days of absences from day care centre [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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
Days of antibiotic use [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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
Days of medical office visits or emergency visits [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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.
Direct and Indirect costs [ Time Frame: January 2011 to June 2011 ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	269
Study Start Date:	January 2011
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Dietary Supplement: Lreuteri 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.
Placebo Comparator: Placebo The placebo consists of an identical formulation except that the L. reuteri is not present	Other: Placebo The placebo consists of an identical formulation except that the L. reuteri is not present

Arms

Assigned Interventions

Experimental: 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.

Dietary Supplement: Lreuteri

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.

Placebo Comparator: Placebo

The placebo consists of an identical formulation except that the L. reuteri is not present

Other: Placebo

The placebo consists of an identical formulation except that the L. reuteri is not present

Eligibility

Ages Eligible for Study:	6 Months to 36 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249911

Contacts

Contact: Pedro Gutierrez-Castrellon, MD, MSc, DSc	+525510840906	pedrogtzca@prodigy.net.mx
Contact: Gabriel Lopez-Velazquez, PhD	+525510840900	glv_1999@yahoo.com

Sponsors and Collaborators

National Institute of Pediatrics, Mexico

Investigators

Principal Investigator:	Pedro Gutierrez-Castrellon, MD, MSc, DSc	National Insitute of Pediatrics, Mexico
Study Director:	Gabriel Lopez Velazquez, PhD	National Institute of Pediatrics, Mexico

More Information

Publications:

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. Epub 2010 Aug 16.

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. Epub 2010 Jun 12.

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, Björkstén 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.

Böttcher MF, Abrahamsson TR, Fredriksson M, Jakobsson T, Björkstén 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. Epub 2008 Jan 22.

Abrahamsson TR, Jakobsson T, Böttcher MF, Fredrikson M, Jenmalm MC, Björkstén 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. Epub 2007 Mar 8.

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.

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.

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.

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.

Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Møller 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.

Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Møller 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.

Shornikova AV, Casas IA, Mykkänen H, Salo E, Vesikari T. Bacteriotherapy with Lactobacillus reuteri in rotavirus gastroenteritis. Pediatr Infect Dis J. 1997 Dec;16(12):1103-7.

Shornikova AV, Casas IA, Isolauri E, Mykkänen 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.

Responsible Party:	Pedro Gutierrez Castrellon, National Pediatric of Pediatrics, Mexico
ClinicalTrials.gov Identifier:	NCT01249911 History of Changes
Other Study ID Numbers:	LreuteriMexico
Study First Received:	November 28, 2010
Last Updated:	November 29, 2010
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by National Institute of Pediatrics, Mexico:

Infants

ClinicalTrials.gov processed this record on May 22, 2013