Study on the Effectiveness of Simethicone in Water for the Treatment of Gastrointestinal Disorders in Newborns
Gastrointestinal disorders in newborns, such as bloating and infant colic, are common conditions that can cause significant discomfort for both infants and their parents. These disorders are often a source of concern as they can affect the newborn’s well-being and impact family rest and harmony.
Scientific research has long been focused on finding safe and effective solutions to alleviate these symptoms, particularly emphasizing products that can improve children’s quality of life without significant side effects.
Our medical device, based on Simethicone in water, is CE-certified in compliance with Regulation (EU) 2017/745 MDR (Medical Device Regulation), ensuring the highest standards of safety and efficacy. The certification, obtained in January 2023, confirms the product’s compliance with European regulatory requirements for medical devices, providing a reliable and high-quality solution for treating gastrointestinal disorders in newborns.
Study Objective
The study involved 20 newborns, with the primary objective of evaluating the effectiveness of Simethicone in improving gastrointestinal symptoms. The evaluation was conducted using a specific questionnaire, GIQLI, which measures gastrointestinal disorders through a series of questions related to symptoms such as abdominal pain, bloating, aerophagia, and other signs of flatulence.
Methodology
The questionnaire was administered to participants before and after treatment with Rilefast CE Oral Drops. The collected data was analyzed using various statistical analysis software, including MS Excel®, R, and G*Power.
Data Analysis
The data was examined to identify variations in the overall GIQLI score and the frequency of the six main monitored gastrointestinal symptoms:
- Abdominal pain
- Tension in the upper abdomen
- Abdominal bloating
- Aerophagia
- Strong burping
- Abdominal sounds
Each symptom was assessed before and after treatment to determine whether Simethicone was effective in reducing both the frequency and intensity of each disorder.
Results
The graph highlights the results of the GIQLI test, comparing the scores obtained by participants before (t0) and after (t1) treatment with Simethicone in water Rilefast CE Oral Drops. A significant improvement in gastrointestinal symptoms is observed, with a remarkable increase in the average GIQLI score, rising from approximately 5 to over 20. This indicates that the treatment had a positive and significant impact on participants’ well-being, significantly reducing gastrointestinal disorders.
Furthermore, the clinical study results, conducted on newborns under 6 months old treated with our Simethicone-based medical device in water, demonstrate a marked improvement in gastrointestinal symptoms after two weeks of treatment. Specifically, the following benefits were observed:
- Abdominal pain: 95% reduction
- Bloating: 100% reduction
- Aerophagia: 95% reduction
- Burping: 95% reduction
These data confirm the effectiveness of the treatment in improving newborns’ quality of life by significantly reducing common gastrointestinal symptoms such as pain, bloating, and burping.
Conclusions
Preliminary analysis results suggest that Rilefast CE Oral Drops has shown a significant reduction in gastrointestinal symptoms in newborns. Initial conclusions indicate that the treatment is safe and potentially effective in improving the quality of life of newborns suffering from infant colic and bloating.
As medical device manufacturers, our in-house expertise enables us to offer ready-to-market products and develop custom formulations for private label, meeting the specific needs of each client. Our mission is to ensure products that meet the highest standards of innovation, quality, and safety, providing effective and tailored solutions.
If you are interested in becoming a distributor of our CE-certified Simethicone-based medical device in compliance with Regulation (EU) 2017/745 MDR, either in private label or out-licensing, we are ready to support your growth and provide customized solutions for your market. Our commitment to quality and customer satisfaction makes us the ideal partner to expand your healthcare product portfolio.