1. Infant Colic Drops Relief from digestive discomfort Helps natural sleep CLINICAL STUDIES

2. TABLE OF CONTENTS 1. Clinical Studies A trial of lactase in the management of infant colic Improvement of symptoms in infant colic following the reduction of lactose load with lactase

3. CLINICAL STUDIES A trial of lactase in the management of infant colic Objective: To investigate transient lactose intolerance as a factor in the aetiology of infant colic. Design: We undertook a randomised, double-blind, crossover trial of lactase and placebo drops added to milk formula to determine whether this method of reducing lactose intake affected infant colic. Subjects: Infants with colic were referred from clinics in keeping with Wessel’s modified criteria. Interventions: Infants were randomly allocated to add either lactase or placebo drops to their formula feeds for 1 week followed by 2 days “wash out”. The addition was changed for the second week so that subjects serve as their own control. The formulas were kept refrigerated for 24h before ingestion. The parents kept a diary of their baby’s crying time.

4. Results: Thirteen babies completed the trial, of whom nine were boys. The average birth weight was 3.7kg (8.2 lbs). Colic symptoms began in less than 1 month in 12 babies. The effect of the lactase was to reduce crying time by 1.14h per day. The reductions in crying time was significant. Conclusion: The authors concluded that transient lactose intolerance may have a role in the aetiology of infant colic. Lactase drops require prior incubation with milk formula to be effective. The response to lactase in this study supports “colic”, i.e. spasm of the large intestine as a factor in these infants discomfort.

5. CLINICAL STUDIES Improvement of symptoms in infant colic following the reduction of lactose load with lactase Objective: To investigate improvement of symptoms in infant colic following the reduction of lactose load with lactase. Methods: The trial design was that of a randomised double-blind two-period crossover study. Fifty-three infants aged between 3 and 13 weeks were recruited and randomly received lactase or placebo arm for an initial period of 10 days, and then switched after a 5-day wash-out phase, during which neither lactase nor placebo was used, to 10 days in the alternate arm. Mother’s were trained to use the drops both in breast feed and formula feed.

6. Results: Of the 53 babies who entered the trial, 46 subjects were available for cry time analysis, and breath hydrogen data were available in 34 subjects. Data Analysis of the study showed that lactase pre treatment of feeds was associated with markedly and statistically significant lower breath hydrogen than was the case with placebo pre-treatment. The predetermined criteria for treatment success (>45% reduction in cry time and breath hydrogen) were achieved by 26% of babies overall, and by 38% of compliers. p.p.m: parts per million

7. Conclusion: The authors concluded that the pre-incubation of feed with lactase was associated with a significant difference in both cry time and breath hydrogen in those who used lactase as indicated. These findings suggest that infant colic may have a multiple aetiology, and that in a significant number of cases the immediate cause is transient lactose intolerance, in which cases pre-treatment of feeds with lactase can result in considerable symptomatic benefits. Reduction in Breath and Crying Levels