N/A
Completed N=44
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Source: ClinicalTrials.gov NCT02750501 ↗Enrolled (actual)
44
Serious AEs
2.4%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA) — 5.01 percentage of omega-3 composition
Summary
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA) |
5.01 | — |
| SECONDARY Unanticipated Adverse Device Effects (UADE) |
10; 2; 8 | — |
| SECONDARY Changes in Plasma Concentration Total DHA+EPA |
93.73 | — |
| SECONDARY Erythrocyte Composition (%) of DHA |
3.28 | — |
| SECONDARY Erythrocyte Composition (%) of EPA |
1.73 | — |
| SECONDARY Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids |
-2.51 | — |
| SECONDARY Plasma Composition (%) Ratio of n6/n3 Fatty Acids. |
-6.29 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of cystic fibrosis
- Documented history of exocrine pancreatic insufficiency
- Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
- Written informed consent or assent.
Exclusion Criteria
- Uncontrolled diabetes mellitus
- Signs and symptoms of liver cirrhosis or portal hypertension
- Lung or liver transplant
- Active cancer currently receiving cancer treatment
- Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease
Data sourced from ClinicalTrials.gov (NCT02750501). 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. Informational only — not medical advice.