Infantile colic, commonly referred to as cramps in babies, is not a disease but a transient condition classified as a functional disorder of the digestive system. Such disorders occur without a clearly defined organic cause and are often part of intestinal maturation in early life (Vandenplas et al., Journal of Pediatric Gastroenterology and Nutrition, 2015).
The causes of colic are not fully understood and remain the subject of numerous studies, but they are believed to be related to the immaturity of the digestive system and the baby’s adaptation to the external environment (Benninga et al., StatPearls, 2023).
Colic most commonly appears in the second or third week after birth and is most pronounced between the third and sixth week of life. It is characterized by episodes of intense, inconsolable crying, often without an obvious cause.
Although it can be very stressful for parents, colic is, in most cases, transient and resolves spontaneously by the end of the third, and at the latest by the fifth month of life (Benninga et al., StatPearls, 2023).
Due to its nature, infantile colic is considered a developmental and transient condition that does not leave lasting consequences.
Sources
Vandenplas Y et al. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants. Journal of Pediatric Gastroenterology and Nutrition. 2015;61(5):531–537.
A systematic review confirming that colic is a functional disorder and that its causes are not fully understood.
https://pubmed.ncbi.nlm.nih.gov/26308317/
Benninga MA et al. Infantile Colic — StatPearls. 2023.
A review describing the course, frequency, and spontaneous resolution of colic in early life.
https://www.ncbi.nlm.nih.gov/books/NBK518962/
Babytol® Coli are oral drops intended to support the digestive tract of newborns and infants, combining the probiotic Lactobacillus reuteri and the enzyme lactase.
The enzyme lactase is involved in the breakdown of the milk sugar lactose, thereby facilitating milk digestion in the infant digestive system. Clinical studies show that reducing the lactose load with the use of lactase may help reduce symptoms of colic and abdominal discomfort (Kanabar et al., Journal of Human Nutrition and Dietetics, 2001).
Lactobacillus reuteri is a bacterium that can naturally be found in breast milk and in the infant’s gut microbiota as early as the first month of life, and is therefore associated with the early development of a healthy gut microbiome in newborns.
The combination of probiotics and the enzyme lactase acts on multiple levels of the digestive system — supporting the balance of gut flora and facilitating lactose breakdown, which may contribute to reducing discomfort associated with infant colic.
Sources
Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. Journal of Human Nutrition and Dietetics. 2001;14(5):359–363.
A randomized study showing a reduction in colic symptoms with lactase use.
https://pubmed.ncbi.nlm.nih.gov/11906576/
Asenova A, Hristova H, Ivanova S, Miteva V, Zhivkova I, Stefanova K, Moncheva P, Nedeva T, Urshev Z, Marinova-Yordanova V, Georgieva T, Tzenova M, Russinova M, Borisova T, Donchev D, Hristova P, Rasheva I. Identification and Characterization of Human Breast Milk and Infant Fecal Cultivable Lactobacilli Isolated in Bulgaria: A Pilot Study. Microorganisms. 2024;12(9):1839. doi:10.3390/microorganisms12091839.
It is recommended to administer five drops from each bottle before every breastfeeding session or meal, in order to ensure continuous support for the digestive system throughout the entire day.
Administration before feeding plays an important role, as it allows the enzyme lactase to be present in the digestive tract at the moment when milk or formula reaches the intestines, thereby facilitating the breakdown of lactose and reducing the burden on the digestive system.
Consistent use before each feeding may help reduce abdominal discomfort, which can positively affect sleep quality and enable calmer days and nights, both for the baby and for the parents.
Source
A meta-analysis confirming a reduction in crying and colic symptoms in infants with the use of L. reuteri.
https://pubmed.ncbi.nlm.nih.gov/29279326/
Lactase is an enzyme that enables the breakdown of the milk sugar lactose into simpler sugars that are more easily absorbed in the small intestine. In the first months of life, the digestive tract of newborns and infants is still immature, which may result in reduced production of this enzyme (Heyman et al., Pediatrics, 2006).
When there is not enough lactase, lactose is not fully broken down in the small intestine but instead reaches the large intestine, where it is fermented by intestinal bacteria. This process leads to gas production, increased intestinal pressure, and discomfort that manifests as cramps and inconsolable crying (Kanabar et al., Journal of Human Nutrition and Dietetics, 2001).
This condition is most often transient and related to the maturation of the digestive system, so symptoms usually resolve around the fourth month of life (Heyman et al., Pediatrics, 2006).
The use of the enzyme lactase with milk or infant formulas enables more efficient lactose breakdown in the digestive tract, thereby reducing the amount of undigested lactose and consequently alleviating symptoms of colic and abdominal discomfort (Kanabar et al., Journal of Human Nutrition and Dietetics, 2001).
Sources
Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. Journal of Human Nutrition and Dietetics. 2001;14(5):359–363.
A study confirming the link between lactose fermentation, gas production, and colic symptoms, as well as the effect of lactase.
https://pubmed.ncbi.nlm.nih.gov/11906576/
Heyman MB. Lactose intolerance in infants, children, and adolescents. Pediatrics. 2006;118(3):1279–1286.
Guidelines describing lactase immaturity in early life and the spontaneous resolution of symptoms.
https://pubmed.ncbi.nlm.nih.gov/16951027/
The development of a baby’s digestive system begins during pregnancy and continues intensively after birth through the process of gut microbiota colonization. During this early period, a balance is established between different bacterial cultures that play an important role in the functioning of the digestive system and the overall development of the child.
Lactobacillus reuteri is a bacterium that can naturally be found in breast milk and in the infant’s gut microbiota as early as the first month of life, and is therefore associated with the early development of a healthy gut microbiome in newborns.
Sources
Asenova A, Hristova H, Ivanova S, Miteva V, Zhivkova I, Stefanova K, Moncheva P, Nedeva T, Urshev Z, Marinova-Yordanova V, Georgieva T, Tzenova M, Russinova M, Borisova T, Donchev D, Hristova P, Rasheva I. Identification and Characterization of Human Breast Milk and Infant Fecal Cultivable Lactobacilli Isolated in Bulgaria: A Pilot Study. Microorganisms. 2024;12(9):1839. doi:10.3390/microorganisms12091839.
Lactobacillus reuteri – for the digestive tract of newborns
Lactobacillus reuteri is a bacterium that can naturally be found in breast milk and in the infant’s gut microbiota as early as the first month of life, and is therefore associated with the early development of a healthy gut microbiome in newborns.
Sources
Asenova A, Hristova H, Ivanova S, Miteva V, Zhivkova I, Stefanova K, Moncheva P, Nedeva T, Urshev Z, Marinova-Yordanova V, Georgieva T, Tzenova M, Russinova M, Borisova T, Donchev D, Hristova P, Rasheva I. Identification and Characterization of Human Breast Milk and Infant Fecal Cultivable Lactobacilli Isolated in Bulgaria: A Pilot Study. Microorganisms. 2024;12(9):1839. doi:10.3390/microorganisms12091839.
Lactase – enzyme for lactose breakdown and easier digestion
Lactase is a digestive enzyme that breaks down the milk sugar lactose into simpler sugars that are more easily absorbed in the intestines. In early life, when the digestive system is still maturing, additional lactase intake may contribute to more efficient milk digestion.
By reducing the amount of undigested lactose in the intestines, the process of fermentation and gas formation is decreased, which may help alleviate symptoms of colic and abdominal discomfort in infants (Kanabar et al., Journal of Human Nutrition and Dietetics, 2001).
Source
Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. Journal of Human Nutrition and Dietetics. 2001;14(5):359–363.
A study confirming that lactase use improves digestion and reduces colic symptoms in infants.
https://pubmed.ncbi.nlm.nih.gov/11906576/
Five drops from each bottle, before every feeding
It is recommended to administer five drops from the bottle containing Lactobacillus reuteri and five drops from the bottle containing the lactase enzyme, before each breastfeeding session or meal.
Administration before feeding allows lactase to be present in the digestive tract at the moment when milk reaches the intestines, ensuring more efficient lactose breakdown and reducing the likelihood of gas formation and cramps (Kanabar et al., Journal of Human Nutrition and Dietetics, 2001).
Consistent use before every feeding, both during the day and night, provides continuous digestive support during the period when colic symptoms are most pronounced.
Sources
Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. Journal of Human Nutrition and Dietetics. 2001;14(5):359–363.
A study confirming the effectiveness of lactase in reducing colic symptoms.
https://pubmed.ncbi.nlm.nih.gov/11906576/
My baby, given that he was born by caesarean section, received the permitted doses of Babytol Neonate from the first day, and Babytol Coli since we came home. We had no problems with cramps. Actually, maybe there were, but they were very mild, the stool was neat. The baby just breastfeeds and today, after almost 4 months, we don't have any problems and we still use Coli. I think that a month or so is enough and that would be it. I am more than satisfied with the preparations!
In modern medicine, infantile colic is defined as a functional disorder of the digestive system rather than a disease. This means that it occurs without a clearly identified organic cause and is most often associated with the immaturity of the digestive tract in early life.
The diagnosis of colic is based on clinical criteria, with the most widely accepted framework being the Rome IV criteria. According to these guidelines, infantile colic is characterized by episodes of intense and inconsolable crying in an otherwise healthy infant, without an obvious reason, occurring during the first months of life (Zeevenhooven et al., Pediatric Gastroenterology, Hepatology & Nutrition, 2017).
The Rome IV criteria further emphasize that colic occurs before the age of five months and has a transient nature, with a tendency to resolve spontaneously as the digestive system matures.
Although clearly defined through clinical behavioral patterns, the exact causes of infantile colic are still not fully understood and remain the subject of ongoing research.
Source
Zeevenhooven J, Koppen IJN, Benninga MA. The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatric Gastroenterology, Hepatology & Nutrition. 2017;20(1):1–13.
A study defining the Rome IV criteria for the diagnosis of functional gastrointestinal disorders in infants.
https://pubmed.ncbi.nlm.nih.gov/28401050/
One of the hypotheses regarding the development of infantile colic links symptoms to incomplete lactose breakdown in the digestive tract of infants. In conditions of reduced lactase enzyme activity, part of the lactose reaches the large intestine, where it is fermented, which may lead to gas formation and abdominal discomfort.
Results from randomized, controlled clinical trials show that the use of the lactase enzyme may help reduce the duration and intensity of crying in infants with colic. Studies have reported significant improvement in symptoms in groups receiving lactase compared to placebo or control groups (Narang and Shah, BMC Pediatrics, 2022; Ahmed et al., JPMA, 2018).
The most recent systematic review of randomized clinical trials further confirms these findings, indicating that lactase supplementation may have a clinically significant effect in reducing symptoms of infantile colic in infants (Nau et al., Journal of Pediatric Gastroenterology and Nutrition, 2024).
Based on available evidence, the use of lactase represents one of the nutritional support options that may contribute to alleviating colic symptoms in infants.
Sources
Narang M, Shah D. Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial. BMC Pediatrics. 2022;22(1):468.
A study showing a reduction in crying duration and colic symptoms with lactase use.
https://pubmed.ncbi.nlm.nih.gov/35922776/
Ahmed M, Billoo AG, Iqbal K, Memon A. Clinical Efficacy of Lactase Enzyme Supplement in Infant Colic. JPMA. 2018;68(12):1744–1747.
A randomized study confirming the clinical efficacy of lactase.
https://pubmed.ncbi.nlm.nih.gov/30504935/
Nau AL, Bassan AS, Cezar AB, de Carlos GA, Deboni M. Lactase for infantile colic: A systematic review of randomized clinical trials. Journal of Pediatric Gastroenterology and Nutrition. 2024;79(4):855–862.
A systematic review summarizing evidence on the effectiveness of lactase.
https://pubmed.ncbi.nlm.nih.gov/38720550/
Please note that the referenced clinical studies and scientific sources relate to individual product ingredients and their effects, not to the product as a whole.
Babytol Neonate and Babytol COLI can be administered simultaneously. The doses are adjusted so that there is no danger if used together. The use of good bacteria in children is generally safe, even when given in high doses
As a rule, colic occurs two weeks after birth, and is most intense between weeks 3 and 6. In most cases, they spontaneously stop by the end of the third month, at the latest by the fifth month of life.
Babytol Coli For You! are oral drops containing the culture of beneficial bacteria Lactobacillus reuteri and the enzyme lactase. It is added to breast milk or milk formula, and is intended for the digestive tract in newborns and infants from birth to 4 months of age. Lactase is added to breast milk, or milk formulas, in order to break down lactose - a complex sugar from milk into simple sugars, thus facilitating digestion and reducing the occurrence of abdominal cramps in newborns and infants up to the age of 4 months
The recommended daily dose is 5 drops from both vials before each feeding/meal.
The causes of the phenomenon have not been fully clarified and are still the subject of numerous studies.
Lactase is added to breast milk, or milk formulas, in order to break down lactose, thereby facilitating digestion and reducing the occurrence of abdominal cramps(colic) in newborns and infants.
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