Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elgan Pharma Ltd.
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
2. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
3. After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption.
You may not be if
1. Subject has undergone any bowel lengthening procedure.
2. Subject has a malabsorption disorder due to:
* congenital etiology (such as microvilli inclusion disease, tufting enteropathy)
* Untreated Hirchsprung's disease
3. Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.
4. Subjects with hyperinsulinemia.
5. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
Clareo Health | Safety and Efficacy Study in Infant With SBS
