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Published on: January 27, 2019
A randomized clinical trial comparing the efficacy of probiotic drops and sucrose in managing colic in early infancy
Fateme Zaker Tavallaie1, Mitra Azra Aldaghi2, Seyedmorteza Rasti Sani1
1Department of Pediatrics, School of Medicine Heshmatie Hospital, Sabzevar University of Medical Sciences, Sabzevar, Iran.
Insights
Pedilact probiotic drops may offer a safe, natural alternative for infant colic, showing comparable improvements to sucrose in reducing crying and improving sleep. Further research is recommended for confirmation.
Area of Science:
- Pediatrics
- Gastroenterology
- Microbiome Research
Background:
- Infantile colic affects 10-40% of infants globally, causing caregiver distress.
- Current management strategies include probiotics and sucrose, with distinct proposed mechanisms of action.
- A randomized controlled trial (RCT) was conducted to compare Pedilact probiotic drops and 20% sucrose solution for colic management.
Purpose of the Study:
- To compare the efficacy of Pedilact probiotic drops versus 20% sucrose solution in managing infantile colic.
- To evaluate the impact of these interventions on infant feeding duration, crying hours, and sleep duration.
Main Methods:
- 120 breastfed infants aged 1-5 months diagnosed with colic were randomized.
- Participants received either Pedilact drops or a 20% sucrose solution.
- Primary outcomes were assessed at baseline, 14 days, and 21 days.
Main Results:
- Significant differences in feeding duration, crying hours, and sleep duration were observed between groups at 14 and 21 days.
- Both interventions demonstrated similar improvement trends over the study period.
- Repeated measures ANOVA confirmed significant between-group differences, with identical progression of improvement.
Conclusions:
- Pedilact probiotic drops show preliminary evidence as a safe, natural complementary therapy for colic symptoms.
- Results suggest Pedilact may be comparable to sucrose in managing colic.
- Larger, blinded trials are necessary to validate findings and address limitations like parental reporting bias.
Background And Aim:
Infantile colic, characterized by prolonged crying episodes in otherwise healthy infants, affects 10-40% of babies worldwide. Although self-limiting, it causes significant caregiver distress and disrupts infant development. Probiotics may alleviate colic symptoms by modulating gut microbiota and reducing inflammation, while sucrose has been shown to reduce crying by activating endogenous opioid pathways. This randomized controlled trial (RCT) compared the efficacy of Pedilact probiotic drops versus a 20% sucrose solution in managing colic.
Methods:
A total of 120 breastfed infants aged 1-5 months with colic were randomly assigned to receive either Pedilact drops or 20% sucrose solution. Primary outcomes (feeding duration, crying hours, and sleep duration) were assessed at baseline and after 14 and 21 days of treatment.
Results:
Significant differences were observed between the two groups in feeding duration, crying hours, and sleep duration at the 14- and 21-day follow-ups. However, both groups showed similar trends of improvement over time. Repeated measures ANOVA confirmed significant between-group differences in these outcomes, while the progression of improvement was identical in both groups.
Conclusion:
This study provides preliminary evidence that Pedilact probiotic drops may serve as a safe and natural complementary therapy for reducing colic symptoms compared to sucrose alone. However, larger blinded trials are needed to validate these findings and address limitations such as reliance on parental reporting.
Trial Registration:
This study was IRCT registration number: IRCT20230625058574N1 (Registration date: 2023-07-27).
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