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Published on: January 27, 2019
Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized
Flavia Indrio1, Antonio Di Mauro1, Giuseppe Riezzo2
1Department of Pediatrics, Aldo Moro University of Bari, Bari, Italy.
Insights
Probiotic supplementation with Lactobacillus reuteri DSM 17938 in newborns significantly reduced colic, reflux, and constipation. This intervention also lowered associated healthcare costs for families and communities.
Area of Science:
- Neonatal Health
- Gastroenterology
- Microbiome Research
Background:
- Infantile colic, reflux, and constipation are common functional gastrointestinal disorders in infants under 6 months.
- These conditions lead to significant socioeconomic burdens, including hospitalizations, medication use, and parental work absence.
Purpose of the Study:
- To evaluate the efficacy of Lactobacillus reuteri DSM 17938 oral supplementation in preventing infantile colic, gastroesophageal reflux, and constipation in newborns.
- To assess the impact of this probiotic intervention on the socioeconomic consequences of these common infant conditions.
Main Methods:
- A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial involving 589 term newborns.
- Infants received daily L. reuteri DSM 17938 or placebo for the first 90 days of life.
- Data collected included crying duration, regurgitation, constipation, healthcare visits, and parental workdays.
Main Results:
- L. reuteri DSM 17938 significantly reduced daily crying time (38 vs. 71 minutes), regurgitations (2.9 vs. 4.6 per day), and constipation.
- The probiotic group showed a significant difference in daily evacuations (4.2 vs. 3.6).
- Supplementation resulted in estimated savings of €88 per family and €104 per community.
Conclusions:
- Prophylactic use of L. reuteri DSM 17938 effectively reduces the incidence of functional gastrointestinal disorders in the first three months of life.
- This probiotic intervention offers significant cost-benefit advantages for both families and public healthcare systems.
Importance:
Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences.
Objective:
To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions.
Design:
A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatal units in Italy between September 1, 2010, and October 30, 2012.
Setting:
Parents were asked to record in a structured diary the number of episodes of regurgitation, duration of inconsolable crying (minutes per day), number of evacuations per day, number of visits to pediatricians, feeding changes, hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days.
Participants:
In total, 589 infants were randomly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days.
Interventions:
Prophylactic use of probiotic.
Main Outcomes And Measures:
Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation.
Results:
At 3 months of age, the mean duration of crying time (38 vs 71 minutes; P < .01), the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L reuteri DSM 17938 and placebo groups, respectively, were significantly different. The use of L reuteri DSM 17938 resulted in an estimated mean savings per patient of €88 (US $118.71) for the family and an additional €104 (US $140.30) for the community.
Conclusions And Relevance:
Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.
Trial Registration:
clinicaltrials.gov Identifier: NCT01235884.
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