At a glance
ClinicalIndex Comparison RecordN/ACompleted· 45 enrolled
Drug / intervention
Physiomanna® Babydietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Physiomanna® Baby for Irritable Bowel Syndrome Characterized by Constipation. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
Primary CompletionApr 2016
First PostedApr 2016
TodayJul 2026
First PostedApr 11, 2016
Enrollment StartFeb 1, 2016
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.2 years ago
Interventions
Physiomanna® Babydietary
Dosage 1g/kg body, 2 cycles (if applicable)