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

• Number of responders vs. non-responders [ Time Frame: Baseline, at 7, 14 and 21 days ] [ Designated as safety issue: No ]
  Number of responders versus non-responders with L. reuteri versus placebo at the time points 7, 14, and 21 days. Responder is defined as a decrease in daily average crying time of 50% during the study as measured using the maternal daily diary.
• Parental quality of life [ Time Frame: Daily for 21 days ] [ Designated as safety issue: No ]
  Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)
• Number of episodes of crying [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]
  Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo
• Duration of episodes of crying [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]
  Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo
• Changes in stool consistency [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]

Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment.

We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo.

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's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.

Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

• Biological: Biogaia L. reuteri DSM 17938
  Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
• Biological: Probiotic Placebo
  Description of Placebo: contains same excipients as Active Agent, without the active ingredient

• Experimental: Biogaia L. reuteri DSM 17938
  Intervention: Biological: Biogaia L. reuteri DSM 17938
• Placebo Comparator: Placebo
  Intervention: Biological: Probiotic Placebo

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