NCT00658905

Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Replacement Therapy in Preterm Infants

Interventions

Type	Name	Description
DRUG	rhBSSL	0.15 g/L rhBSSL added to infant formula; one week treatment
DRUG	Placebo	One week treatment

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-04-16
• Last updated: 2014-11-03

Locations

6 sites across 1 country: Italy