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Vitamine suppletion by morbide obase patient

Optimization of the supplementation of vitamins and minerals1. In patients who received a gastric banding for treatment for their morbid obesitya. Reduction of iron deficiencyb. Reduction of Vitamin B12 deficiencyc. Reduced Vitamin D deficiency2. In…

Influence of the dietary history in the prevention of coeliac disease : possibilities of induction of tolerance for gluten in genetically predisposed children. The dutch food intervention study

1. Development of a prevention strategy for CD in children from high risk families for the disease by induction of oral tolerance to gluten;2. Identification of the immunological mechanisms involved in initiating the aberrant response to gluten…

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…

A randomized, placebo-controlled, double-blind, parallel arms study to evaluate the pharmacokinetic and pharmacodynamic relationship of multiple subcutaneous injections of apraglutide in healthy volunteers.

1. A better understanding of the apraglutide dose/concentration-effect relationship;2. A better understanding of duration of effect (apraglutide kinetics in relation to citrulline kinetics).

Tailoring Limb length based on total small bowel length in omega-loop gastric bypass

To investigate whether adjusting the length of the BP-limb of the OAGB based on measured total small bowel length leads to more weight loss, resolution of co-morbidities with less development of micronutrient deficiencies and bowel movements…

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 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 RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION

Primary Objective: Proof of safety and tolerability of home parenteral nutrition (HPN) with an Omega-3 fatty acid enriched MCT/LCT lipid emulsion in adult patients with chronic intestinal failure (CIF) in need of long-term HPNSecondary Objectives:…

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…