NCT00659243

Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants

A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk 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: 32 (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 pasteurized breast milk.

Detailed description

In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk 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 pasteurized breast milk; one week treatment
DRUG	Placebo	One week treatment

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-04-16
• Last updated: 2014-11-03

Locations

8 sites across 2 countries: France, Italy