Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants
Primary Purpose
Healthy Infants
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lreuteri
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Infants focused on measuring Infants
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lreuteri
Placebo
Arm Description
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.
The placebo consists of an identical formulation except that the L. reuteri is not present
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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.
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
Full Information
NCT ID
NCT01249911
First Posted
November 28, 2010
Last Updated
November 29, 2010
Sponsor
National Institute of Pediatrics, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01249911
Brief Title
Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Pediatrics, Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Infants
Keywords
Infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lreuteri
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo consists of an identical formulation except that the L. reuteri is not present
Intervention Type
Dietary Supplement
Intervention Name(s)
Lreuteri
Intervention Description
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 Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo consists of an identical formulation except that the L. reuteri is not present
Primary Outcome Measure Information:
Title
days with diarrhoea
Description
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.
Time Frame
January 2011 to June 2011
Secondary Outcome Measure Information:
Title
Days with respiratory tract infections (RTI)
Description
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
Time Frame
January 2011 to June 2011
Title
Days of absences from day care centre
Description
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
Time Frame
January 2011 to June 2011
Title
Days of antibiotic use
Description
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
Time Frame
January 2011 to June 2011
Title
Days of medical office visits or emergency visits
Description
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.
Time Frame
January 2011 to June 2011
Title
Direct and Indirect costs
Description
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
Time Frame
January 2011 to June 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Gutierrez-Castrellon, MD, MSc, DSc
Phone
+525510840906
Email
pedrogtzca@prodigy.net.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Lopez-Velazquez, PhD
Phone
+525510840900
Email
glv_1999@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Gutierrez-Castrellon, MD, MSc, DSc
Organizational Affiliation
National Insitute of Pediatrics, Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriel Lopez Velazquez, PhD
Organizational Affiliation
National Institute of Pediatrics, Mexico
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20713478
Citation
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Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants
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