Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02732743
Status:
COMPLETED
Last Update Posted:
2019-10-24
First Post:
2016-03-31
Brief Title:
Food Supplement Physiomanna Baby in Pediatric Patients
Sponsor:
Iuppa Industriale Srl
Organization:
Iuppa Industriale Srl
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 products administration in the enrolled children
The secondary objective of the trial is to evaluate the adherence to products 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
The tested hypothesis is that Physiomanna Baby administration for 3 weeks increases the SBM to be more than 2 times per week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None