Trial on the efficacy of a medical device (Rilefast Ace) based on simethicone and silicon dioxide in the treatment of infant colic
Inconsolable crying in infants not only causes concern for parents but can also lead to significant consequences, such as an increased risk of postpartum depression in mothers and premature cessation of breastfeeding. In many cases, mothers suspect that breast milk might be causing the baby’s discomfort, leading them to stop breastfeeding.
Infant colic refers to intense, inconsolable crying in otherwise healthy infants, typically occurring in the first few months of life. These episodes can cause considerable stress for parents. The diagnosis of colic is based on clinical criteria, with special reference to the Rome IV Criteria, which are used to classify functional gastrointestinal disorders in children and adults.
According to the Rome IV Criteria, infant colic is characterized by:
– Age of the child: colic occurs in healthy infants between 2 weeks and 4 months.
– Crying and irritability: the crying is excessive, inconsolable, and not due to obvious causes such as hunger, pain, or illness.
– Duration of episodes: the crying must last for at least 3 hours a day, at least 3 days a week, and continue for at least 1 week.
This is commonly known as the “rule of 3.”
Despite the prevalence of this condition, there is no definitive treatment for infant colic. Parents often try various remedies to relieve their baby’s discomfort.
Among these, products containing simethicone are commonly used to reduce colic symptoms, as they are thought to help coalesce air bubbles in the stomach and intestines, thus reducing bloating. However, scientific evidence regarding the efficacy of simethicone is limited and conflicting.
The goal of our trial was to evaluate the efficacy of a medical device containing simethicone in combination with silicon dioxide (Rilefast Ace) in the treatment of infant colic, to determine whether this formulation could offer concrete benefits in reducing symptoms.
Trial Method
In this trial, we conducted a retrospective multicenter evaluation of the medical records of 63 patients aged 2 to 6 weeks who underwent a 14-day treatment with an oral formulation (Rilefast ACE drops, PJPHARMA) containing simethicone and silicon dioxide.
The Neonatal Infant Pain Scale (NIPS) after feeding was assessed before and after treatment. NIPS is a multidimensional scale used in both preterm and full-term infants. It includes categories such as facial expression, crying, breathing, movements of the upper and lower limbs, and the infant’s alertness. The final score ranges from 0 to 7, with 0 indicating no pain and 7 indicating maximum pain. (Spence K et al., 2005)
Trial Results
The Neonatal Infant Pain Scale (NIPS) scores after feeding were significantly reduced after the 14-day treatment period (5.03 ± 1.36 vs. 1.22 ± 1.45, p<0.001). A positive correlation was found between the absolute difference in NIPS scores and pre-treatment NIPS (beta=0.88, p=0.001), birth weight (beta=2.39, p=0.009), and baseline weight (beta=1.58, p=0.026). A negative correlation was observed between formula feeding and improvement in NIPS values (beta=-2.04, p=0.015).
In conclusion, the results suggest that the simethicone and silicon dioxide formulation present in our Class IIb medical device, certified under MDR (Rilefast ACE), may offer significant improvements in the symptoms of infant colic. A notable reduction in both the duration of crying and the pain associated with colic was observed, with particularly effective results in infants who had higher initial distress.
If you are interested in becoming a distributor of the Rilefast Ace medical device in a ready-to-market line or private label or would like more information on our clinical trial