Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy
infants with colic. Patients will be randomized to receive either L. reuteri at one dose
orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory
assessment of safety and tolerability. The time on study treatment is 6 months, and the
target sample size is 45 healthy infants.

Secondly, the investigators aim to gather evidence supporting hypothesis of safety and
tolerability of Lactobacillus reuteri by administering a physical examination and testing of
complete blood count, liver tests, and serum electrolytes over a forty-two day period.

Inclusion Criteria:

- Full-term babies with colic (21-90 days old, who cry/fuss > 3h daily x > 3d wk)

- baby must have more than 3h crying for enrollment

Exclusion Criteria:

- severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of
milk > 8 times daily, projectile, bilious or bloody emesis)

- failure to thrive

- intrauterine growth retardation

- hematochezia (blood in the stools)

- diarrhea (watery stools that takes the shape of a container > 5x daily)

- fever (38.2 degrees)

- Premature infants (<37 wk gestation)