Phase 2
N=15
Use of Pancreatic Enzymes in Short Bowel Syndrome
Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03097029 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Coefficient of Fat Absorption — 2.3 percentage of fat absorbed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pancreatic Enzyme (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Coefficient of Fat Absorption |
2.3 | — |
| SECONDARY Change in the Coefficient of Nitrogen Absorption |
6.9 | — |
Summary
Patients with short bowel syndrome have a high mortality rate that is mainly attributed to complications from central lines and long-term intravenous (IV) nutrition. There are few medical therapies to date that improve gut absorption in patients with short bowel syndrome. The primary objective of this study is to evaluate if absorption from the GI tract improves in subjects with short bowel syndrome following therapy with pancreatic enzymes.
Eligibility Criteria
Inclusion Criteria
- history of a small bowel resection with subsequent dependence on parenteral nutrition for at least three months
- age 4 years to 65 years
- usual state of health for the past two weeks with no medication changes
- able to participate in a study for about four weeks with four study visits
- able to take pancreatic enzyme medication orally
Exclusion Criteria
- significant disease other than short bowel syndrome affecting the gastrointestinal tract that impacts absorption or digestions
- motility disorder
- medications that directly alter fat absorption
- cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0 mg/dL, chronic renal failure, gout, or hyperuricemia
- history of a pork allergy
- women who are pregnant or lactating
- history of fibrosing colonopathy
Those subjects who are eligible for the malabsorption blood test (MBT) test will be excluded if they have a history of a soy or safflower oil allergy.
Data sourced from ClinicalTrials.gov (NCT03097029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.