Irritable Bowel Syndrome Characterized by Constipation Clinical Trial
Official title:
An Open Label, Non-comparative Pilot Study to Assess the Efficacy and Safety of the Food Supplement Physiomanna® Baby in Pediatric Patients With a History of Functional Constipation
The primary objective is to assess the efficacy and safety of the Food Supplement
Physiomanna® Baby in pediatric patients with a history of functional constipation
The secondary objective of the trial is to evaluate the adherence to product's administration
in the enrolled children.
This is an interventional, non-controlled, multicenter trial with a prospective design in one
cohort of patients. This clinical investigation will be performed in 3 centers in Romania.
The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM
to be more than 2 times per week.
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