NCT02732743

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Iuppa Industriale Srl · Academic / Other
• Sex: All
• Age: 1 Week – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Irritable Bowel Syndrome Characterized by Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Physiomanna® Baby	Dosage 1g/kg body, 2 cycles (if applicable)

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-04-11
• Last updated: 2019-10-24

Locations

1 site across 1 country: Romania