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

Sobi

Status and phase: Completed; Phase 2

Conditions: Replacement Therapy in Preterm Infants

Treatments: Drug: Placebo; Drug: rhBSSL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659243

BVT.BSSL-021

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Preterm infants
• less than or equal to 32 weeks of gestational age
• appropriate for gestational age
• enterally fed with pasteurized breast milk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

rhBSSL

Experimental group

Treatment:

Drug: rhBSSL

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo