Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants

Healthy Infants Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01249911
• Other study ID #: LreuteriMexico
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 28, 2010
• Last updated: November 29, 2010
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: National Institute of Pediatrics, Mexico
• Contact: Pedro Gutierrez-Castrellon, MD, MSc, DSc
• Phone: +525510840906
• Email: pedrogtzca[@]prodigy.net.mx
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 269
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Infants

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Pediatrics, Mexico

References & Publications (14)

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. — View Citation

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. doi: 10.1097/MPG.0b013e31818f091b. — View Citation

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. doi: 10.1111/j.1399-3038.2007.00687.x. Epub 2008 Jan 22. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days with diarrhoea	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	No
Secondary	Days with respiratory tract infections (RTI)	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	No
Secondary	Days of absences from day care centre	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	No
Secondary	Days of antibiotic use	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	No
Secondary	Days of medical office visits or emergency visits	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	No
Secondary	Direct and Indirect costs	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	No