Many studies target probiotic therapy for specific conditions such as colic, regurgitation, and constipation.

Many studies target probiotic therapy for specific conditions such as colic, regurgitation, and constipation.

Functional gastrointestinal disorders (FGIDs) are defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities.

Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders (FGIDs) that lead to referral to a paediatrician during the first six months of life and are often responsible for hospitalisation, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences.

Recent work indicates a crucial role of the intestinal microbiota in the pathogenesis of gastrointestinal disorders as in FGIDs, and many studies target probiotic therapy for specific conditions such as colic, regurgitation, and constipation. The effect of a probiotic could play a crucial role in the modulation of intestinal inflammation.

Many studies target probiotic therapy for specific conditions such as colic, regurgitation, and constipation.

Many studies target probiotic therapy for specific conditions such as colic, regurgitation, and constipation.

RANDOMISED CLINICAL TRIAL:

Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation

OBJECTIVE

To investigate whether oral supplementation with Lactobacillus reuteri DSM  17938 during the first three months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term new-borns and thereby reduce the socioeconomic impact of these conditions.

DESIGN

A prospective, multi-centre, double-masked, placebo-controlled randomised clinical trial was performed on term new-borns (age <1 week) born at nine different neonatal units in Italy between 1 September 2010, and 30 October 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 paediatricians, feeding changes, hospitalisations, visits to a paediatric 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 three months of life. Cost-benefit analysis of the probiotic supplementation.

RESULTS

At three months of age, the mean duration of crying time (38 vs 71 minutes; P < 0.01), the mean number of regurgitations per day (2.9 vs 4.6; P < 0.01), and the mean number of evacuations per day (4.2 vs 3.6; P < 0.01) 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 R1 478 for the family and an additional R1 747 for the community.

CONCLUSIONS AND RELEVANCE

Prophylactic use of L reuteri DSM 17938 during the first three months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

IMPORTANT

Different probiotic strains have different effects on the human body – the strain and dosage on the commercially sold product should always be the same as the clinical trial to ensure the claim is correct.

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