Simethicone and Silica Dioxide for Infant Colic: Gruppo FarmaImpresa Clinical Trial on Efficacy and Benefits
Infant colic is characterized by excessive crying and irritability in otherwise healthy infants, with a variable prevalence worldwide. This condition can be associated with a higher risk of maternal depression and shaken baby syndrome.
Behavioral and dietary interventions, such as improving breastfeeding techniques, and using probiotics, or hypoallergenic formulas, have shown some benefits but lack definitive clinical results.
Among pharmacological treatments, simethicone is commonly used to reduce intestinal gas.
Our medical device combines simethicone and silica to improve abdominal air expulsion, supported by coenzyme Q and vitamins E and A (Rilefast CE).
Evaluation of Intestinal Gas in Infants and Treatment with Simethicone and Silica Dioxide
One month after birth (T0), the presence of intestinal gas in infants was assessed through ultrasound, using the EcoTOT score and measuring the distance between the aorta and the linea alba (LAAM). The EcoTOT score is an ultrasound index used to quantify intestinal gas accumulation, handy for monitoring infants with colic. This method allows for verifying the effectiveness of specific treatments to reduce gas content.
Subsequently, a 14-day treatment of simethicone combined with silica dioxide (Rilefast CE) was administered. During this period, caregivers kept a daily diary to record colic episodes, providing detailed data on symptom improvement.
The ultrasound examination was repeated at the end of the 14-day treatment period (T1) to compare results with the initial level of intestinal gas.
Figure 1 – A) Reduction in LAAM from baseline to follow-up; B) Ultrasound measurement of LAAM
Fifteen days after stopping the treatment (T2), caregivers were interviewed to assess the overall improvement of symptoms, allowing for a comprehensive evaluation of the treatment’s efficacy and safety.
Trial Results: Significant Reduction in Intestinal Gas and Colic Episodes
The study included a total of 40 infants. At follow-up, the measurement of the LAAM distance (distance between the aorta and the linea alba) was significantly reduced compared to baseline values (p<0.0001), indicating a decrease in intestinal gas content after treatment.
Additionally, colic episodes were significantly reduced, both at the first post-treatment check (T1) and 15 days after discontinuation (T2), with a significance level of p<0.0001 for each time-point comparison.
Correlation analysis provided further insights into the results obtained. A positive correlation was observed between LAAM measurement and the frequency of colic episodes (r=0.35), suggesting that a greater LAAM distance is associated with a higher frequency of colic episodes.
In addition, a negative correlation emerged between time and colic episodes (r=-0.84) and between time and LAAM measurement (r=-0.63), indicating a progressive reduction in both intestinal gas levels and colic episodes as treatment progressed.
This investigation showed that the combination of simethicone and silica dioxide in our medical device (Rilefast CE) is promising in reducing abdominal distension and excessive crying episodes during the 14-day treatment.
If you are interested in becoming a distributor of the Rilefast CE medical device in a ready-to-market line or private label or would like more information on our clinical trial
