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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Institute of Pediatrics, Mexico.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier:
NCT01249911
First received: November 28, 2010
Last updated: November 29, 2010
Last verified: November 2010

November 28, 2010
November 29, 2010
January 2011
April 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01249911 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy Infants
  • 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
  • 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.
    Intervention: Dietary Supplement: Lreuteri
  • Placebo Comparator: Placebo
    The placebo consists of an identical formulation except that the L. reuteri is not present
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
269
June 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 36 Months
Yes
Contact: Pedro Gutierrez-Castrellon, MD, MSc, DSc +525510840906 pedrogtzca@prodigy.net.mx
Contact: Gabriel Lopez-Velazquez, PhD +525510840900 glv_1999@yahoo.com
Not Provided
 
NCT01249911
LreuteriMexico
Yes
Pedro Gutierrez Castrellon, National Pediatric of Pediatrics, Mexico
National Institute of Pediatrics, Mexico
Not Provided
Principal Investigator: Pedro Gutierrez-Castrellon, MD, MSc, DSc National Insitute of Pediatrics, Mexico
Study Director: Gabriel Lopez Velazquez, PhD National Institute of Pediatrics, Mexico
National Institute of Pediatrics, Mexico
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP