Observational studyItalian journal of pediatrics2025
Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study on behalf of Italian Society of Pediatrics (SIP).
Observational study in Italian journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06458881 (EFFICACY OF A MIXTURE OF SIMETHICONE AND TYNDALLIZED BACILLUS COAGULANS IN INFANT COLIC), which is not on this map. Not yet cited in PubMed.
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Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study
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11 authors.
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Abstract
backgroundInfant colic is a common functional gastrointestinal disorder characterized by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of a mixture of Tyndallized Bacillus Coagulans and Simethicone in reducing the crying time in colicky infants and improving quality of sleep and infants' and parents' quality of life.
methodsA pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life.
resultsForty-one infants were enrolled, two didn't complete the study. In 89% of patients, we observed at least a 50% reduction in crying time at 28 days post-intervention. This success rate was significantly higher (p < 0.001) compared to a physiological reduction in newborn/infant crying, estimated at 39%. We observed that the mean daily crying time at the end of the treatment was significantly lower (p < 0.001). Regarding the sleep duration we found a significantly longer diurnal and nocturnal sleep at 28th day (p < 0.001 and p < 0.001, respectively). In addition, a significant improvement of mothers' and fathers' quality of life and severity perception of IC was detected at 28th day (p < 0.001 and p < 0.001, respectively). No relevant adverse events were observed.
conclusionsTyndallized bacillus coagulans and Simethicone seems to be promising in the management of infants with colic. Nevertheless, further studies are needed to confirm this preliminary data.
trial registrationClinicalTrial.gov, NCT06458881. Registered 11 June 2024-Retrospectively registered.
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