Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure (GLP-2-01)
Intestinal Failure, Short Bowel Syndrome
About this trial
This is an interventional treatment trial for Intestinal Failure focused on measuring Infant Nutrition Disorders, Childhood nutrition disorders, malnutrition, post surgical syndromes, necrotising enterocolitis, intestinal atresia, gastroschisis
Eligibility Criteria
Inclusion Criteria:
- Infants (< 1 year corrected gestational age) Infants with congenital anomalies, or intestinal resection, leaving them with anatomic short bowel syndrome (total remaining small intestine less than 40 % of predicted for gestational age) will be eligible for treatment in the immediate post-operative period.
- Infants with intestinal resection or repaired gastroschisis who have demonstrated dependence on parenteral nutrition at 45 days post operation with the requirement for >50% of calories by PN (independent of the length of remnant small intestine).
- Children (> 1 year corrected gestational age) Children with a requirement for >30% of calories by PN more than 1 year (365) days post surgery will be eligible.
Exclusion Criteria:
- Significant extra-intestinal disease (e.g., grade IV intraventricular hemorrhage, severe hypoxic encephalopathy);
- Significant cardiovascular, hemodynamic or respiratory instability, as noted by 1) the requirement for dopamine > 4 mcg/kg/min, 2) high frequency ventilatory support, 3) extracorporeal membrane oxygenation.
- Hepatic disease defined as direct bilirubin > 100 umol/L (5.2 mg/dL)
- Renal disease defined as BUN > 80 or creatinine > 90 μmol/L (1.5 mg/dL)
- Inborn errors of metabolism necessitating protein restriction or other special diet;
- Ongoing sepsis syndrome, as noted by refractory hypotension, thrombocytopenia, acidosis, and/or bacteremia.
- Primary motility defect such as intestinal pseudo-obstruction.
- Absorptive defects (such as microvillus inclusion disease)
- Females who are post-pubertal must agree to comply with measures to prevent pregnancy during the study phase.
- Coagulopathy which precludes the use of subcutaneous injections.
- Allergy to GLP-2 or any of the constituent of the GLP-2 IC-115 preparation.
Sites / Locations
- Alberta Children's Hospital
- Stollery Children's Hospital
- British Columbia Children's Hospital
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intestinal Failure in children (>1 year)
GLP-2 in Infants (<1 year of age)
Children requiring parenteral nutrition for >30% of calories more than 1 year (365) days post surgery will be eligible for treatment with Glucagon-like peptide 2 (20 ug/kg/day) for 6 weeks
Infants under one year of age with congenital anomalies, or intestinal resection, leaving them with anatomic short bowel syndrome (total remaining small intestine less than 40 % of predicted for gestational age) or with intestinal resection or repaired gastroschisis who have demonstrated dependence on parenteral nutrition at 45 days post operation with the requirement for >50% of calories by PN (independent of the length of remnant small intestine) will be eligible for treatment with Glucagon-like peptide 2, at a dose of 5, 10 or 20 ug/kg/day.