Eliminates the Cause of Infant Colic

Delictase® is a food supplement in the form of
oral drops or powder in capsules. Delictase®
is intended to be used in cases of digestive
disorders (colic) caused by transient lactose
intolerance in infants and newborns
(oral drops) or lactose intolerance
in children and adults (capsules).
Delictase® digests the lactose in the milk,
not only alleviating the symptoms of lactose
intolerance but eliminating the cause of colic.
Delictase® Oral Drops is safe
to be used since birth.

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BABY COLIC


Causes of Infant Colic

The incidence of infant colic appears to be independent of whether the child is breastfed or fed with artificial formulas. The etiology of colic in infants is not fully known. It is believed the causes of colic in a young child can be motivated by:

Lactose Intolerance

Lactose intolerance can be a major cause of colic in infants but can also have a significant impact in the quality of life of children and adults.

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Food Allergy

Among the dietary factors that contribute to food allergy in infants, a special attention is given to the interdependence of infant colic with hypersensitivity or allergy to cow's milk protein. This specific allergy is largely due to the immaturity of the intestinal barrier of the baby, the undeveloped digestive tract or family history (heredity). Also, the inclusion of some foods in the mother’s diet - such as caffeine, spicy food, etc. - may be transferred to the breastmilk and from there to the breastfed infant and cause undesirable reactions to the baby.

Intestinal microflora disorders

Within a few hours after birth, the infant’s gut is colonized by numerous bacteria, as part of the natural growth process. However, depending on the composition of the gastrointestinal bacterial flora – which varies with the diet, medication or emotional state of the baby and its surroundings - some of these can cause gastrointestinal discomfort or illness, affecting the health of the baby.

Incorrect feeding technique

Breastfeeding is the best for your baby and you should always prefer breastfeeding over infant formula. Nowadays, more attention is being given to the feeding technique. In breastfed infants, it is important the baby’s mouth covers the whole halo and not only the nipple while sucking. As a consequence of a wrong feeding technique, air can be swallowed contributing to abdominal distension and pain. A similar situation leading to swallowing air can occur during artificial feeding if the baby bottle is not positioned correctly or the teat is too big or too small.

Psychosocial factors

Psychosocial disorders are often referred to as dysfunctional interactions between the child and the mother or as a result of a dysfunctional family. A young child, despite the apparent "unconsciousness" of its surroundings, is a true barometer of emotions. The baby has a strong non-verbal contact with its parents and senses the emotional atmosphere of the environment. Even very small children can feel stress and bad emotions in their immediate surroundings and manifest it with a variety of somatic symptoms, such as irritability, appetite disorders, colic or constipation.

LACTOSE INTOLERANCE


Transient Lactose Intolerance is a common cause of colic in infants. Transient Lactose Intolerance occurs when the baby's digestive system is unable to digest lactose, which is the main carbohydrate found in breast milk as well as in infant formulas.
Transient Lactose Intolerance in newborns might be caused by insufficient production of endogenous lactase by the infant’s immature gut. Babies that still don’t have the ability to produce enough lactase endogenously can’t fully digest the lactose content ingested with the milk. As a consequence, these large lactose molecules pass through a process of alternative digestion by the intestinal microflora which leads to the production of hydrogen, carbon dioxide and methane. These byproducts cause bloating, flatulence and abdominal pain. Undigested lactose acidifies in the colon and increases the osmotic load, resulting in loose stools and diarrhea1.

Delictase® naturally eliminates the cause of colic by providing an exogenous source of lactase, the enzyme necessary for the correct digestion of lactose.

Apart from the gastro intestinal disorders, the crying, the cramps and the pain experienced by the colicky baby, there is also the nutritional aspect of the problem that is usually not so evident (sometimes neglected). By not digesting the lactose in the milk, the baby is deprived from 2 crucial sugars: glucose and galactose. Glucose itself is the main source of energy for all body functions including the brain function and brain development. Therefore, the inability of the baby to digest lactose has a visible impact (cramps, pain and infant colic) and an invisible impact (development, nutritional) in the baby’s wellbeing. Colic motivated by deficient lactase production, should always be addressed with the objective of eliminating the cause of colic but also to allow a proper diet to the baby.

Delictase® naturally digests the lactose content in the milk, allowing the baby to receive crucial nutrients for its development.

Around the age of 4-5 months, the baby should be able to produce enough endogenous lactase to digest the lactose from milk but even after the weaning period (which usually starts around month 6), milk is still an important part of the diet and parents should be alerted to the fact the baby might take longer to produce lactase and therefore, colic might persist during that period as well.

However, a significant part of the human population is unable to digest lactose. Approximately 75% of the world’s population loses the ability to digest lactose at some point, while others can digest lactose into adulthood2. Reduction in lactase activity causes primary maldigestion of lactose, a condition that is occasionally asymptomatic. When symptoms are present, lactose intolerance is diagnosed2.


Geographic Lactose Intolerance Prevalence in the Human Population
(according to the Food Intolerance Network™) 6
Lactose Intolerance

The inability to produce enough endogenous lactase (also called hypolactasia) does not cause any disturbance or discomfort unless lactose containing food is consumed. Some authors have reported that the clinical presentation of lactose intolerance is not restricted to gut symptoms. Systemic complaints, such as headache, vertigo, memory impairment, lethargy, muscle and joint pains, allergy, cardiac arrhythmia, mouth ulcers and sore throat, have been reported in less than 20% but up to 86% of these patients3,4.

The initial recommendation for management of lactose intolerance in adults is to aim for remission of symptoms by temporarily avoiding milk and dairy products. After the initially restricted diet, lactose should be gradually reintroduced until the patient’s threshold for symptoms is reached5. At this point, several behavioral measures can be adopted to overcome possible symptoms, including having fermented and matured milk products in the diet, consuming lactose together with other foods, etc.

If the suggested measures do not suffice in reducing symptoms, other strategies can be implemented, such as lactase supplements.

1. Lomer MC, Parkes GC, Sanderson JD. Review article: lactose intolerance in clinical practice - myths and realities. Aliment Pharmacol Ther. 2008;27:93-103.
2. R Mattar, DF de Campos Mazo, FJ Carrilho. Lactose intolerance: diagnosis, genetic, and clinical factors. Clinical and Experimental Gastroenterology 2012:5 113-121
3. Matthews SB, Waud JP, Roberts AG, Campbell AK. Systemic lactose intolerance: a new perspective on an old problem. Postgrad Med J. 2005;81:167-173.
4. Harrington LK, Mayberry JF. A re-appraisal of lactose intolerance. Int J Clin Pract. 2008;62:1541-1546
5. Montalto M, Curigliano V, Santoro L, et al. Management and treatment of lactose malabsorption. World J Gastroenterol. 2006;12:187–191.
6. https://www.food-intolerance-network.com/food-intolerances/lactose-intolerance/ethnic-distribution-and-prevalence.html


Delictase® is a lactase enzyme in 2 different forms:

Delictase® Oral Drops
Delictase® Oral Drops

Delictase® Oral Drops should be used in newborns suffering from infant colic. Delictase® Oral Drops acts in the cause of infant colic by allowing a proper digestion of lactose. Undigested lactose molecules pass through a process of alternative digestion by the intestinal microflora which leads to the production of hydrogen, carbon dioxide and methane. These byproducts cause bloating, flatulence and abdominal pain. Undigested lactose acidifies in the colon and increases the osmotic load, resulting in loose stools and diarrhea. Delictase® Oral Drops naturally eliminates the cause of colic by providing an exogenous source of lactase, the enzyme necessary for the correct digestion of lactose. Some innovative characteristics of Delictase® Oral Drops:

  • Safe from birth
  • No need for incubation of the product before use. Simply pour a few drops of product directly to the baby’s mouth or the baby bottle and feed the baby immediately after
  • No need for refrigeration
  • Manufactured in the European Union in a production site certified with Good Manufacturing Practices (GMP) and in compliance to the Hazard Analysis and Critical Control Point (HACCP) guidelines
  • High lactase content (>3.000 ALU at the end of the 24 months shelf life)
  • Currently sold in 20+ countries in 4 continents
  • More than half a million happy babies without colic after using Delictase® Oral Drops since the product launch in 2008 (2017 estimated)

Delictase® Capsules
Delictase® Capsules

Delictase® Capsules should be used by children and adults suffering from lactose maldigestion or lactose intolerance. In the case of children or adults with difficulty in swallowing, the capsules content can by poured in a glass of water.
As Delictase® Oral Drops, the Capsules act in the cause of lactose maldigestion or lactose intolerance, by enhancing the proper digestion of lactose, allowing children and adults suffering for this health condition to intake dairy products such as milk, cheese, yogurt, etc.
Each capsule of Delictase® contains 3.000 ALU (lactase measuring unit) and the recommended posology is 2 capsules of Delictase® taken before all lactose containing meals.
According to the European Food Safety Agency (EFSA), with a minimum recommended dose of 4500 FCC units (Food Chemicals Codex, similar measure to ALU) with each lactose containing meal, the ingested lactase enzyme contributes to breaking down lactose1.
EFSA panel of experts also considered that the dose may have to be adjusted to individual needs.
Delictase® Capsules is manufactured in the European Union in a production site certified with Good Manufacturing Practices (GMP) and in compliance to the Hazard Analysis and Critical Control Point (HACCP) guidelines.

1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of health claims related to lactase enzyme and breaking down lactose (ID 1697, 1818) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2009; 7(9):1236

Distributors


Companies with active operations in the healthcare industry, interested in evaluating the opportunity of distributing Delictase in their markets should contact:

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