Effect of lactase supplementation on infant colic: Systematic review of randomized controlled trials.

To systematically review evidence on the efficacy and safety of using a lactase supplementation for managing infant colic. The MEDLINE, EMBASE, and Cochrane Library databases were searched (up to September 2023) for randomized controlled trials (RCTs) comparing oral lactase supplementation with placebo or no intervention in infants younger than 6 months old with infant colic. The risk of bias was assessed using the revised version of the Cochrane risk-of-bias tool. Outcomes measured were selected according to a standardized core outcome set. Five RCTs involving a total of 391 infants were identified. Three RCTs reported reduced crying duration, but one showed effect only in a compliant group (40.4%, p = 0.0052). A meta-analysis of two RCTs found no difference in crying duration and fussing time during 1 week of lactase treatment compared with placebo (mean difference [MD] -17.66 min/day, 95% confidence interval [CI], -60.8 to 25.5; I2 = 68% and MD 2.75, 95% CI, -58.2 to 57.2; I2 = 80%, respectively). Other outcomes were assessed only in individual studies or not reported. The risk of bias was low in only one RCT, high in three, and raised some concerns in one. While individual trials have shown some promise, the overall evidence for the efficacy of lactase supplementation in treating infant colic remain inconclusive. Further well-designed RCTs are necessary to determine the effects of lactase on managing infant colic.

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

Infant colic is a common functional gastrointestinal disorder that affects infants during their first months of life. The etiology of this condition remains unclear. However, some studies suggest lactase deficiency may be a contributing factor. Currently, the evidence on dietary treatment and lactase supplementation for management of infant colic is limited. We aim to systematically review evidence on the efficacy and safety of using a lactase supplementation for managing infant colic. The Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE, and EMBASE will be searched to identify randomized controlled trials comparing oral lactase supplementation with placebo or no intervention in infants aged less than 6-month-old with infant colic using any recognized definition. The risk of bias will be assessed using the second version of the Cochrane Collaboration's risk-of-bias tool. The main outcome will be the number of responders in each group after treatment, defined as infants who experienced a decrease in daily crying as reported by the study authors. Additional outcomes will include the duration and frequency of crying episodes, infant sleep duration, parental satisfaction, discomfort of infants, number of hospital admissions, family quality of life, and adverse events during the intervention. The study findings will be published in a peer-reviewed journal and will be submitted to relevant conferences.

Retrospective and Prospective Determination of the Cow's Milk-Related Symptom Score (CoMiSS™) Values in Symptomatic Infants.

PURPOSE: The Cow's Milk-related Symptom Score (CoMiSS™) was developed as an awareness tool for evaluating cow's milk-related symptoms in otherwise healthy children. Using a convenience sample of participants, this cross-sectional study aimed to determine CoMiSS™ values of symptomatic infants based on retrospectively or prospectively obtained information. METHODS: CoMiSS™ values were determined in infants aged <12 months with symptoms suggestive of cow's milk protein allergy or functional gastrointestinal disorders. The exclusion criteria were previous diagnosis with acute or chronic disease, treatment with a therapeutic formula, and in case of breastfeeding, an elimination diet followed by the mother. Two CoMiSS™ values were assessed. A retrospective collection was defined as the collection of data after initial contact with the medical center but before the first medical consultation. A prospective collection was defined as the collection of data within 24 hours from the time of medical consultation but before starting any therapeutic intervention. The CoMiSS™ total and individual component scores obtained retrospectively or prospectively were compared between groups using the Wilcoxon signed-rank test. RESULTS: This study was performed between August and November 2019. Data of 110 children (62 males and 48 females), with a mean±standard deviation age of 18.2±11.7 weeks, were obtained. The total CoMiSS™ value (p<0.001) and some individual component scores (crying, regurgitation, and stool) were significantly lower when collected prospectively than when collected retrospectively. CONCLUSION: CoMiSS™ values were retrospectively and prospectively determined. Lower CoMiSS™ values were obtained during prospective evaluation. Possible differences should be considered when using CoMiSS™ in clinical practice.