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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
  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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 20, 2014