Efficacy and Safety of Limosilactobacillus reuteri DSM 17938 in Infantile Colic: A Narrative Review From Pathogenesis to Clinical Practice.
- 2026-04-27
- Cureus 18(4)
- Kimberly Carvajal Méndez
- Ana Gabriela Álvarez Barrientos
- Freddy Gutiérrez Rivera
- Daniel Aragón Leiva
- Dennis Ulate Fuentes
- PubMed: 42211616
- DOI: 10.7759/cureus.107824
Study Design
- Type
- Review
- Population
- infants with infantile colic
- Methods
- narrative review synthesizing clinical evidence
Infantile colic is one of the most common functional gastrointestinal disorders, affecting approximately 20% of infants worldwide. Characterized by paroxysmal episodes of inconsolable crying and fussing without an obvious cause, the condition imposes a significant psychosocial burden on the family unit, acting as a primary trigger for maternal postpartum depression, parental exhaustion, and premature cessation of breastfeeding. Despite its prevalence, traditional management in primary care remains heterogeneous and often ineffective, leaving a substantial therapeutic gap. Emerging research has identified gut dysbiosis as a cornerstone of its pathogenesis, where an imbalance in early microbial colonization, characterized by reduced diversity and a higher prevalence of gas-producing coliforms, triggers intestinal inflammation and visceral hypersensitivity through the gut-brain axis. This narrative review synthesizes the current clinical evidence regarding the efficacy and safety of Limosilactobacillus reuteri DSM 17938 in the management of infantile colic. This specific probiotic strain exerts its therapeutic effects through multifaceted mechanisms, including the production of the antimicrobial metabolite reuterin, the modulation of gastrointestinal motility via microvesicles, and the reduction of low-grade gut inflammation. Clinical evidence from large-scale meta-analyses confirms that L. reuteri DSM 17938 is significantly superior to placebo, particularly in breastfed infants, where it is twice as likely to achieve a 50% reduction in crying time within 14-21 days of treatment. However, its efficacy appears less predictable in formula-fed populations, potentially due to the absence of synergistic factors found in human milk. Clinical management in primary care should prioritize a rigorous diagnostic approach to rule out organic causes through a detailed physical examination and the application of the Rome IV criteria. The cornerstone of non-pharmacological management remains empathetic parental reassurance and education to mitigate the risk of infant abuse and support family well-being. When probiotic intervention is indicated, L. reuteri DSM 17938 represents a robust, evidence-based first-line therapy for healthy, full-term infants. Regarding safety, this strain maintains an excellent profile supported by its generally recognized as safe (GRAS) status, with no significant adverse effects reported in healthy populations. Nevertheless, recent clinical scrutiny emphasizes the need for caution and the use of pharmaceutical-grade products in vulnerable groups. Ultimately, L. reuteri DSM 17938 addresses both the biological triggers of colic and the psychosocial stability of the family unit.
Research Insights
Clinical evidence from large-scale meta-analyses confirms that L. reuteri DSM 17938 is significantly superior to placebo, particularly in breastfed infants, where it is twice as likely to achieve a 50% reduction in crying time within 14-21 days of treatment.
- Effect
- Beneficial
- Effect size
- Large
Adverse Events Reported
Regarding safety, this strain maintains an excellent profile supported by its generally recognized as safe (GRAS) status, with no significant adverse effects reported in healthy populations.
- Finding
- Reported