Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

Multicenter, Prospective, Comparative, Randomized Controlled Clinical Trial to Evaluate the Performance and the Safety of Promelaxin® Micro-enemas Vs. Macrogol 4000 Per os in the Treatment of Functional Chronic Constipation in Children Aged Between 6 and 48 Months.

The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.

The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.

Inclusion Criteria:

• Chronic functional constipation according to Rome III criteria
• No stool softeners therapy administered during the 7 days prior to Baseline Visit
• Signature of informed consent from by both parents or legal representative
• Willingness to follow the study schedule

Exclusion Criteria:

• Suspicious or established diagnosis of organic constipation
• Delayed emission of meconium in the term newborn
• Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
• Presence/Risk of gastroinstestinal perforation
• Presence/Suspiceous intestinal obstruction of symptomatic stenosis
• (Undeterminated) Abdominal pain
• Hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients
• Hereditary fructose intolerance
• Known hypersensitivity or allergy to any Promelaxin component
• Presence of any other medical condition that contraindicate the use of Promelaxin® or Macrogol 4000