Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 10:23 AM
Study NCT ID:
NCT00658905
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
Sponsor:
Swedish Orphan Biovitrum
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
Status:
COMPLETED
Status Verified Date:
2014-10
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 purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Detailed Description:
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
Study Oversight
Has Oversight DMC:
True
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?: