Food Supplement Physiomanna® Baby in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT02732743|
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : October 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Characterized by Constipation||Dietary Supplement: Physiomanna® Baby||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Food Supplement Physiomanna® Baby
Dosage: 1g/kg body
Dietary Supplement: Physiomanna® Baby
Dosage 1g/kg body, 2 cycles (if applicable)
- 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 ]
- Investigator and Patient Global Assessment for Efficacy [ Time Frame: 2-3 weeks ]
- Analysis of product's administration adherence by diary cards [ Time Frame: 2-3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732743
|Opera Contract Research Organization SRL|
|Timisoara, Timis, Romania, 300209|
|Study Director:||Barattini Dionisio, MD||Opera CRO|