Clinical Study on Secol: Simethicone in Water for Infant Colic
Gastrointestinal disorders in newborns, such as bloating and colic, are frequent and distressing conditions that affect both infants and caregivers. Episodes of intense crying, abdominal tension, and discomfort often lead to sleep disruption and parental anxiety.
Scientific research focuses on safe, effective solutions that relieve symptoms without significant side effects. In this context, Secol emerges as a CE-certified medical device, based on simethicone in aqueous solution, specifically formulated to treat functional gastrointestinal disorders in infants.
Certified under EU MDR Regulation 2017/745, Secol guarantees safety, efficacy, and regulatory compliance.
Study Objective
This clinical study involved 20 newborns, aiming to evaluate the effectiveness of simethicone in reducing GI symptoms. Symptom assessment was conducted using the GIQLI questionnaire, which measures gastrointestinal issues like abdominal pain, bloating, gas, and burping.
Methodology & Data Analysis
The questionnaire was administered before and after a 14-day treatment with Secol. Data was analyzed using MS Excel®, R, and G*Power, focusing on six main symptoms:
- Abdominal pain
- Upper abdominal tension
- Abdominal bloating
- Aerophagia
- Excessive burping
- Abdominal sounds
Clinical Results
The GIQLI score significantly improved, increasing from an average of 5 to over 20 points after treatment—demonstrating clear symptom relief.
Detailed findings include:
- Abdominal pain: 95% reduction
- Bloating: 100% reduction
- Aerophagia: 95% reduction
- Burping: 95% reduction
These results highlight Secol’s potential to improve infants’ quality of life significantly.
Conclusion
Secol, simethicone in aqueous solution, showed remarkable effectiveness in reducing gastrointestinal symptoms in newborns. The treatment was well-tolerated and significantly improved GI comfort after 14 days of use.
Looking for a B2B-ready or private label solution?
We are certified manufacturers of medical devices, dietary supplements, and cosmetics. Secol is ready for market entry or private labeling, with full regulatory and clinical support.
