Food Supplement Physiomanna® Baby in Pediatric Patients

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.

Inclusion Criteria:

• Male or female outpatients between the ages of 0 to 8 years;
• Functional constipation according to ROME III criteria (Annex 2);
• Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema;
• To be otherwise in good health, as judged by a physical examination;
• Mentally competent parent or tutor to sign an informed consent

Exclusion Criteria:

• Known history of organic cause for the constipation;
• Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases);
• Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks;
• Fecal impaction at baseline, or during the trial period, as indicated by the physical examination;
• Known or suspected perforation or obstruction other than fecal impaction;
• History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy;
• Use of concomitant medications that cause constipation in the previous 3 months;
• Concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs;
• Concomitant use of cardiac glycosides(e.g. Digoxin);
• Patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures;
• Patients with known allergy to Fraxinus Manna, mannitole, fennel, lemon balm or chamomile;
• Patients with clinically significant elevations of TSH or abnormal plasma electrolytes in the 4 previous weeks;
• Patients who, within the past 30 days have participated in an investigational clinical study;