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| Name | Class |
|---|---|
| Alcresta Therapeutics, Inc. | INDUSTRY |
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The goal of this study is to learn if Relizorb, a fat-digesting enzyme, can improve tolerance of tube feeds in adult patients with moderate to severe pancreatitis. The main question it aims to answer is:
Does Relizorb allow more nutrition to be delivered to participants than they received without it?
Participants will be observed with standard, universal monitoring after adding Relizorb to their nutrition regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relizorb treatment | Experimental | Patients with moderate to severe pancreatitis who are not tolerating sufficient enteral nutrition will have a lipase-containing cartridge (Relizorb) placed in-line with their enteral nutrition tubing, to digest the fat in the formula prior to entering the patient's intestine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELiZORB digestive enzyme (immobilized lipase) cartridge | Device | An in-line digestive enzyme cartridge designed for hydrolyzing lipids within enteral nutrition will be used to improve tube feed tolerance in patients with moderate to severe pancreatitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of goal nutrition delivered at 72 hours | Change from baseline in percentage of goal enteral nutrition (kcal/kg/day) received 3 days (72 hours) following initiation of RELiZORB. Baseline is considered the 24 hours prior to RELiZORB start. | From enrollment to the end of treatment at 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of goal nutrition delivered at 24 hours | Change from baseline in goal percentage of enteral nutrition (kcal/kg/day) received 1 day (24 hours) following initiation of RELiZORB. | From enrollment to 24 hours after starting RELiZORB |
| Responders at 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Hansen, MD | Northwell Health | Principal Investigator |
| Rafael Barrera, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Shore University Hospital | Bay Shore | New York | 11706 | United States | ||
| North Shore University Hospital |
Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.
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Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 3 days (72 hours) following initiation of RELiZORB use. |
| From enrollment to end of treatment at 72 hours |
| Responders at 24 hours | Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 1 day (24 hours) following initiation of RELiZORB use. | From enrollment to 24 hours after starting treatment |
| Vomiting | Change in the number of vomiting episodes per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use | From enrollment to completion of treatment at 72 hours |
| Stool volume | Change in stool volume per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use (if rectal tube is in place) | From enrollment to completion of treatment at 72 hours |
| Bowel movements | Change in number of bowel movement episodes in 24 hours from baseline to 24 hours and 72 hours after RELiZORB (if no rectal tube) | From enrollment to completion of treatment at 72 hours |
| Feeding Interruptions | Number of unplanned interruptions in tube feeding from baseline to 24 hours and 72 hours following initiation of RELiZORB use | From enrollment to completion of treatment at 72 hours |
| Manhasset |
| New York |
| 11030 |
| United States |
| Lenox Hill Hospital | Manhattan | New York | 10075 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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