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

National Institute of Pediatrics, Mexico

Status and phase: Unknown; Phase 3

Conditions: Healthy Infants

Treatments: Dietary Supplement: Lreuteri; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01249911

LreuteriMexico

Details and patient eligibility

About

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

Enrollment: 269 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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269 participants in 2 patient groups, including a placebo group

Lreuteri

Experimental group

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.

Treatment:

Dietary Supplement: Lreuteri

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo