COMIL K: simethicone and Saccharomyces boulardii for colic and bloating
Gas colic, abdominal bloating, meteorism and intestinal dysbiosis are very common issues in newborns and children during the first months of life. At this stage, the digestive system and the intestinal microbiota are still immature and can favor the buildup of intestinal gas, abdominal cramps and irritability after feeding.
Pediatric gastrointestinal issues can manifest as inconsolable crying, abdominal tension, digestive difficulties and altered intestinal flora. When bloating and gas colic occur, it can be helpful to use formulations that both reduce the pressure of intestinal gas and support the rebalancing of the microbiota.
COMIL K is a system made up of the medical device Comil Oral Drops and the food supplement based on Saccharomyces boulardii, developed to support gastrointestinal issues associated with gas colic, bloating and intestinal dysbiosis in infants and children.
Developed according to the requirements of the European MDR (Medical Device Regulation) for medical devices. The Comil Oral Drops component is in fact classified as a Class IIb medical device and undergoes rigorous quality and safety controls during the development and manufacturing stages. MDR certification represents one of the highest regulatory standards for medical devices marketed in Europe today, and it guarantees that the product has been developed in compliance with the requirements for safety, quality and clinical performance.
Gas colic and intestinal dysbiosis in children
Gas colic is one of the most common gastrointestinal issues in the first months of life. During this stage, the digestive system and the intestinal microbiota are still maturing and can be particularly sensitive to changes related to feeding and digestive processes.
When excessive gas production or an imbalance of the intestinal bacterial flora occurs, the child may show various symptoms that affect daily comfort and wellbeing after meals.
Among the most frequently associated conditions are:
- gastroenteric meteorism
- aerophagia
- intestinal dysbiosis
- excessive intestinal fermentation
- microbiota imbalances
These issues can manifest with symptoms such as:
- inconsolable crying
- intestinal cramps
- bloating and abdominal tension
- irritability
- digestive discomfort after feeding
In the presence of intestinal dysbiosis, the bacterial flora can lose its physiological balance, favoring fermentation processes and increased gas production. This can contribute to greater abdominal tension and more frequent episodes of colic and irritability, especially in infants and younger children.
What COMIL K is and what it is used for
COMIL K is a system made up of Comil Oral Drops based on simethicone and a sachet containing Saccharomyces boulardii. The formulation was developed to act simultaneously on two aspects often present in pediatric gastrointestinal issues: the buildup of intestinal gas and the imbalance of the bacterial flora.
The combination of simethicone and probiotic offers comprehensive support in situations characterized by bloating, abdominal tension and digestive discomfort.
The product helps to:
- support the elimination of intestinal gas
- reduce pressure in the gastrointestinal tract
- support the balance of the intestinal flora
- improve digestive comfort
- contribute to relief from colic and abdominal cramps
The drop formulation, equipped with a practical pump dropper, also makes administration easier in newborns and children, making the product particularly suitable for use in pediatric age groups.
Simethicone for bloating, meteorism and gas colic
One of the main ingredients of COMIL K is simethicone, present in the oral drops as an aqueous emulsion with a dosage of 40 mg per 20 drops.
Simethicone is widely used for issues associated with the buildup of intestinal gas because it acts on the surface tension of gas bubbles present in the gastrointestinal tract, promoting their merging and subsequent elimination. This mechanism helps reduce the pressure exerted by the gas and improve abdominal comfort.
Thanks to this action, the product helps counter one of the main causes of gastrointestinal discomfort in children, supporting better digestive tolerance after meals.
Saccharomyces boulardii and support for intestinal balance
COMIL K also contains Saccharomyces boulardii, a probiotic widely used in formulations dedicated to children’s intestinal wellbeing.
In the first years of life, the intestinal microbiota plays a fundamental role in digestive processes and in the physiological maturation of the gastrointestinal tract. When this balance is disrupted, dysbiosis can occur, associated with intestinal fermentation, bloating and recurring digestive disorders.
Saccharomyces boulardii helps maintain the balance of the intestinal bacterial flora and supports the restoration of eubiosis in conditions associated with dysbiosis.
A distinctive feature of the formulation is the presence of Saccharomyces boulardii in a separate sachet from the simethicone drops. This solution helps preserve the probiotic’s vitality until the moment of intake, ensuring the stability and quality of the formulation.
The combination of simethicone and Saccharomyces boulardii therefore allows action both on symptoms related to the buildup of intestinal gas and on the factors that can help maintain a proper intestinal environment, offering a comprehensive approach to the most common gastrointestinal issues in newborns and children.
Scientific evidence on the intestinal microbiota and Saccharomyces boulardii
In recent years, scientific research has explored the role of the intestinal microbiota in pediatric gastrointestinal issues, showing how alterations in the bacterial flora can contribute to the onset of gas colic, bloating and digestive discomfort in the first months of life.
Saccharomyces boulardii is one of the most widely studied probiotics in the scientific literature for supporting intestinal balance. A review published on PubMed showed that Saccharomyces boulardii can contribute to supporting the intestinal barrier and rebalancing the microbiota through competitive exclusion of pathogenic microorganisms and modulation of the intestinal environment.
Further scientific evidence has also explored the role of the intestinal microbiota in the first months of life, showing how the balance of the bacterial flora can influence digestion, gastrointestinal comfort and intestinal maturation in infants.
This evidence supports the use of formulations containing probiotics and ingredients beneficial for gastrointestinal wellbeing to help address issues associated with intestinal dysbiosis, bloating and imbalance of the bacterial flora in children.
Looking for a medical device for gas colic and intestinal dysbiosis, ready for market or available for development in private label?
We are certified manufacturers of medical devices, food supplements and cosmetics, and we develop formulations for the gastrointestinal wellbeing of newborns and children. COMIL K is available for B2B and private label projects with full formulation, regulatory and manufacturing support.
Bibliography
- McFarland LV, Li T. Efficacy and safety of Saccharomyces boulardii CNCM I-745 for the treatment of pediatric acute diarrhea in China: a systematic review and meta-analysis. Front Cell Infect Microbiol. 2025 Jun 4;15:1587792. doi: 10.3389/fcimb.2025.1587792. PMID: 40535538; PMCID: PMC12174131.
- Nunez H, Nieto PA, Mars RA, Ghavami M, Sew Hoy C, Sukhum K. Early life gut microbiome and its impact on childhood health and chronic conditions. Gut Microbes. 2025 Dec;17(1):2463567. doi: 10.1080/19490976.2025.2463567. Epub 2025 Feb 7. PMID: 39916516; PMCID: PMC11810090.
