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

> **NCT00659243** · PHASE2 · COMPLETED · sponsor: **Swedish Orphan Biovitrum** · enrollment: 32 (actual)

## Conditions studied

- Replacement Therapy in Preterm Infants

## Interventions

- **DRUG:** rhBSSL
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00659243
- **Lead sponsor:** Swedish Orphan Biovitrum
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2008-03
- **Primary completion:** 2010-02
- **Final completion:** 2010-02
- **Target enrollment:** 32 (ACTUAL)
- **Last updated:** 2014-11-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00659243

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00659243, "Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT00659243. Licensed CC0.

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