Evaluating the impact of lactase supplementation on infant colic: Study protocol for a systematic review of...

Area of Science:

• Pediatrics
• Gastroenterology
• Evidence-based Medicine

Background:

• Infant colic is a prevalent functional gastrointestinal disorder in early infancy.
• The exact causes of infant colic are not fully understood, but lactase deficiency is a potential contributing factor.
• Current evidence on dietary interventions and lactase supplementation for infant colic is limited.

Purpose of the Study:

• To systematically review the efficacy and safety of oral lactase supplementation for managing infant colic.
• To synthesize findings from randomized controlled trials (RCTs) on lactase for infant colic.

Main Methods:

• Systematic review of RCTs comparing oral lactase supplementation with placebo or no intervention.
• Searches conducted in Cochrane CENTRAL, MEDLINE, and EMBASE for infants under 6 months with colic.
• Risk of bias assessed using the Cochrane Collaboration's risk-of-bias tool (Version 2).

Main Results:

• Primary outcome: number of responders (defined as reduced daily crying).
• Secondary outcomes: crying duration/frequency, infant sleep, parental satisfaction, infant discomfort, hospital admissions, quality of life, and adverse events.
• Data synthesis will focus on comparing lactase supplementation to control groups.

Conclusions:

• The review will provide evidence on the effectiveness and safety of lactase supplementation for infant colic.
• Findings will inform clinical practice and future research directions in managing infant colic.
• Results will be disseminated through peer-reviewed publications and conference presentations.