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Protein supplementation after biliopancreatic diversion surgery

Correcting or preventing deficiencies of protein, by means of a protein supplement after a biliopancreatic diversion.

A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide in patients with short bowel syndrome (SBS)

5.1 Primary ObjectiveTo confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.5.2 Secondary ObjectivesTo evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS.To evaluate the safety and…

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

This study has been transitioned to CTIS with ID 2024-513374-22-00 check the CTIS register for the current data. 5.1 Primary ObjectiveTo evaluate the long-term safety of glepaglutide treatment in SBS patients.5.2 Secondary ObjectivesTo evaluate the…

Changes in body composition during and after external beam radiotherapy for gynaecologic cancer

The primary objective of this study is to assess if clinically relevant changes occur in fat free mass (FFM) between baseline and follow up six months after the end of treatment. Our cut-off value of a clinically relevant difference in body…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Primary objective: To assess the efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding. Defined as first day of reaching three consecutive days of…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest

Primary objective: To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile * born at 26-32 weeks GA. * According to Fenton preterm growth chart. Secondary…

A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients with Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

This study has been transitioned to CTIS with ID 2024-513373-43-00 check the CTIS register for the current data. The objectives of this extension trial are to assess the long-term safety and maintenance of efficacy beyond 2 to 2.5 years of treatment…

A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants with Short Bowel Syndrome (SBS) Following Surgical Resection

The primary objective is to evaluate the efficacy and safety of NTRA-9620 compared with placebo when added to standard of care (SOC) in pediatric subjects (aged 28 weeks post-menstrual age to 52 weeks chronological age) with SBS within 4 months from…

A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants.

To assess the efficacy and safety of 2 dose levels of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo.The sub-study aims to determine whether NTRA-2112 in own mother's milk, donor human milk or preterm formula…