Press release
Infantile colic, a new treatment in the pipeline
Specialists and researchers worldwide gathered together at the Symposium entitled “Advances on infantile colic” organised by the Department of Public Health and Paediatric Science of the University of Turin and promoted by the Fondazione Internazionale Menarini.
The causes of infantile colic are still not fully understood and probably derive from various factors, however over recent years attention has been focussing on the role of diet and the intestinal microbial flora.
The discussion at the end of the works addressed the need to carry out good quality studies with more-easily quantifiable objectives that allow for developing specific guidelines with evidence-based effectiveness (Cochrane Library), as well as new treatments offering greater validity.
Research has shown that probiotics, living microorganisms that form colonies in the intestine, might represent a therapeutic strategy thanks to their capacity to interact with the intestinal microbial balance.
Moreover, Phase II studies are underway to evaluate the effectiveness and safety of a new treatment which could become available in the near future.
Infantile colic is a common disorder that occurs during the first three years of life. Although benign and inconsequential, this condition has a considerable impact on family life. Specialists fail to agree about the management and treatment of colic, also because there is currently no permanent therapy, however research that is underway shows promising results for available treatments in the future. The Symposium entitled “Advances on infantile colic” organised by the Department of Public Health and Paediatric Science of the University of Turin and promoted by the Fondazione Internazionale Menarini and held recently in Turin, provided an opportunity for bringing together the world's leading experts who discussed this topic and the new products in the pipeline.
''The onset of colic is accompanied by paroxysmal and inconsolable crying fits, agitation and reddening of the face in infants who are otherwise in good health'', explained Francesco Savino of the Regina Margherita Children's Hospital, City of Health and Science of Turin, and chairman of the Symposium. ''During crying fits the infant may have his/her legs contracted on the abdomen or hyper-distended, clenched fists, eyes wide open or tightly closed, furrowed brow, and a congested face. There may be numerous accompanying symptoms including abdominal distension, meteorism and flatulence. Normally these fits, which are spontaneous and unpredictable, start at the same time each day and are more frequent in the late afternoon or early hours of the evening".
To have an accurate picture of the disorder, the “rule of three” is used according to which an infant suffers from colic if it has paroxysms of irritability with agitation or crying lasting more than three hours a day, occurring at least three days a week, for more than three consecutive weeks.
''The causes of infantile colic are still not fully understood and probably derive from various factors, however over recent years attention has been focussing on the role of diet and the intestinal microbial flora'', explained Savino. ''Several experimental studies suggest that the alteration of the microbial environment in infants suffering from colic could give rise to a dysregulation of the intestinal motor function and an increase in the production of gas with the consequent onset of the painful symptoms typical of this disorder ''.
It has been demonstrated that infants with colic are less frequently colonised by lactobacilli and bifidobacteria compared to healthy infants, and instead they have a higher concentration of anaerobic Gram-negative bacteria.
Based on the results obtained from studies on intestinal dysmicrobism, the possibility has been advanced of acting on the symptoms of infantile colic through the modulation of the intestinal microflora. It has therefore been suggested that probiotics, living microorganisms that form colonies in the intestine could represent a therapeutic strategy thanks to their capacity to interact with the intestinal microbial balance, thus promoting the host's gastrointestinal wellbeing.
A new treatment could also become available in the near future. ''The possible link between infantile colic and a temporary hypersensitivity of the gastrointestinal tract of the newborn during its physical development is at the basis of a hypothesis that a drug able to block visceral pain and alterations to the intestinal motility without changing the baseline parameters, could successfully be used in treating this disorder. It is called Nepadutant, a peptidic molecule and a tachykinin NK2 receptor antagonist. Its pharmacological characteristics, together with its excellent safety and tolerability profile, make this a potential new drug for oral treatment of disorders of the gastrointestinal tract in childhood, in particular, infantile colic''.
Phase II studies are currently underway for evaluating the effectiveness and safety of Nepadutant in over 100 patients suffering from infantile colic.