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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
45
Dosage 1g/kg body, 2 cycles (if applicable)
Opera Contract Research Organization SRL
Timișoara, Timiș County, Romania
Number of Spontaneous Bowel Movements (SBM) per week
Time frame: 2-3 weeks
Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment
Time frame: 2-3 weeks
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