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Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using
F Savino1, S Ceratto1, E Poggi2
1Città della Salute e della Scienza di Torino, Regina Margherita Children Hospital, Dipartimento di Scienze della Sanità Pubblica e Pediatriche, University of Turin, Piazza Polonia 94, 10126 Turin, Italy.
Insights
Lactobacillus reuteri DSM 17938 supplementation can reduce parental discomfort from infantile colic. This probiotic reduced the need for pain relievers, formula feeding, and pediatrician visits in infants.
Area of Science:
- Pediatrics
- Gastroenterology
- Microbiology
Background:
- Infantile colic is a common condition causing significant parental distress.
- Existing treatments for infantile colic have varying efficacy and potential side effects.
- Probiotics, specifically Lactobacillus reuteri, are being investigated for their role in infant gut health.
Purpose of the Study:
- To evaluate the efficacy of Lactobacillus reuteri DSM 17938 combined with vitamin D3 in managing infantile colic.
- To assess the impact of this probiotic intervention on the use of pain-relieving medications and infant formula.
- To determine the effect on healthcare utilization, specifically pediatrician consultations, for infantile colic.
Main Methods:
- A randomized controlled trial involving 113 infants aged less than 10 days with normal physical examinations.
- Infants were assigned to receive either Lactobacillus reuteri DSM 17938 (10^8 cfu) plus vitamin D3 or vitamin D3 alone daily for 12 weeks.
- Primary endpoints included the administration of pain-relieving agents (cimetropium bromide, simethicone) and changes in feeding patterns. Pediatric consultations were also analyzed.
Main Results:
- Lactobacillus reuteri DSM 17938 supplementation showed a significant protective effect, reducing the need for cimetropium bromide (RR 0.04, 95% CI 0.01-0.31) and simethicone (RR 0.24, 95% CI 0.14-0.41).
- A reduced risk of switching to infant formula was observed in the probiotic group (RR 0.37, 95% CI 0.17-0.80).
- The treatment group experienced significantly fewer pediatrician consultations related to infantile colic compared to the control group (P<0.0001).
Conclusions:
- Lactobacillus reuteri DSM 17938 supplementation at the tested dosage is effective in reducing parental discomfort associated with infantile colic.
- The probiotic is associated with a decreased need for pain-relieving medications and a lower incidence of formula feeding.
- Supplementation with L. reuteri DSM 17938 leads to a reduction in healthcare-seeking behavior for infantile colic episodes.
Abstract:
Infants were recruited in four centres in North-West Italy. 138 infants were assessed for eligibility, 113 ones underwent randomisation and 105 completed the study. Newborns aged less than 10 days of life, with gestational age between 37 and 42 weeks, birth weight from 2,500 to 4,300 g and normal physical examination were recruitable. Premature infants and infants affected by outcomes of perinatal hypoxia or necrotising enterocolitis have been excluded. Patients were randomly assigned to receive five drops containing Lactobacillus reuteri DSM 17938 (108 cfu) with 400 UI of vitamin D3 or only 400 UI of vitamin D3 daily. The primary endpoints concern the administration of pain relieving agents (cimetropium bromide at least three times per week or simethicone at least five times per week) from baseline to 12 weeks. Additional analyses were done on the percentage of infants that switched from an exclusive breastfeeding to a partial or exclusive formula feeding from baseline to 12 weeks. Data concerning the number of calls to the paediatricians and the number of visits at paediatricians' ambulatories due to infantile colic have been collected by paediatrician and analysed. Comparing the two groups, the relative risk was 0.04 (95% confidence interval (CI)=0.01-0.31) for cimetropium bromide, 0.24 (95% CI=0.14-0.41) for simethicone and 0.37 (95% CI=0.17-0.80) for the administration of infant formula, showing a protective action of L. reuteri. The treatment group showed a lower number of paediatric consultations related to episodes of infant colic than the control group (P<0.0001). L. reuteri DSM 17938 supplementation at the tested dosage could reduce parental discomfort due to infantile colic. The consumption of this probiotic is associated with a reduction of paediatric consultations for infantile colic, as well as use of pain relieving agents and of infant formula.
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