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Background and Aim <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusion <p>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.</p> Trial registration <p>This study was IRCT registration number: IRCT20230625058574N1 (Registration date: 2023-07-27).</p>

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A randomized clinical trial comparing the efficacy of probiotic drops and sucrose in managing colic in early infancy

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月7日

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  • Fateme Zaker Tavallaie,
  • Mitra Azra Aldaghi,
  • Seyedmorteza Rasti Sani,
  • Parastoo Amiri,
  • Kazem Hassanpour,
  • Neda Raeesi

摘要

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).