Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic

Launched by THE HOSPITAL FOR SICK CHILDREN · Feb 28, 2012

Keywords

ClinConnect Summary

Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys.

The pathogenesis of infantile colic remains elusive despite decades of research. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow'...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy term infant 21-90 days of age
• • 2. Birth weight ≥2500 g
• • 3. Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
• • 4. With colic symptoms (\>3 hours of crying on \>3 days per week) with debut 10 ± 5 days before enrollment
• • 5. Gestational age between 37 and 42 weeks
• • 6. Apgar score higher than 7 at 5 minutes
• • 7. Written informed consent from a parent
• Exclusion Criteria:
• • 1. Any chronic illness or gastrointestinal disorder as judged by the pediatrician
• • 2. Any history of antibiotic treatment or probiotic supplementation
• • 3. Failure to obtain a written consent by parent/legal guardian
• • 4. Participation in other clinical trials
• • 5. Infants with acute illness
• • 6. Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo