Efficacy and Safety of a Colic Relief Remedy in Infantile Colic

Abstract

Infantile colic is the most frequent reason of infant and parental distress. An open-label single-group clinical study was conducted primarily to evaluate the effect of 14-day colic relief remedy administration (1.25 ml orally during colic episode) on average daily crying time in infants compared to baseline. In addition, the percentage of responders, sleep pattern, frequency and severity of gastrointestinal symptoms, tolerability of the product and percentage population with relapse of symptoms post product discontinuation were evaluated. Thirty infants aged 3 to 16 weeks with no significant clinical illness were enrolled in the study with their caregivers. Daily inconsolable crying time and flatulence were significantly reduced (P