Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585735
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Proteolytic Enzyme Fortified Protein Supplement in Patients With Chronic Pancreatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A complex disease Chronic Pancreatitis CP is caused by a wide range of factors including smoking alcoholism autoimmune disorders and obstruction of the major pancreatic duct In patients who are genetically susceptible to the condition these factors can result in damage to the acinar ductal and islet cells as well as persistent inflammatory infiltration and fibrosis Malnutrition is an ongoing concern for persons with CP even though pain is the primary symptom in most cases Complications that commonly arise during the diseases natural history include exocrine and endocrine pancreatic insufficiency and local changes such as pseudocyst biliary and duodenal blockage splenic and portal vein thrombosis and pancreatic cancer Consequently CP mortality is higher than that of the general population
Detailed Description:
Maldigestion due to pancreatic exocrine insufficiency PEI and food avoidance because by pain are two physical causes of malnutrition1 Delayed gastric emptying leads to nausea vomiting and poor oral intake due to duodenal stenosis or extrinsic compressions of the stomach or duodenum from pseudocysts1 Chronic pancreatitis can be difficult to manage nutritionally but there are number of different approaches to help with a customized treatment plan for each patient Patients require comprehensive nutrition care due to the possible combination of malnutrition and insufficient calorie intake Estimated nutritional requirements are 12 to 15 gkg protein and 25 to 35 kcalkg energy12-14 The use of estimated weight-based nutritional requirements raises concerns because it does not account for malabsorption It is unclear from the scant studies in this area whether the nutritional deficiency results from higher energy expenditure impaired nutrient absorption or a combination of the two15
According to international guidelines all patients should have a screening for malnutrition within 24 hours of being admitted to the hospital and those who are at risk ought to receive appropriate nutritional therapies1617 The ongoing disease process in CP increases the requirement for nutrition Most CP patients can be treated with regular diet combined with exogenous pancreatic enzyme supplements 10 to 15 of patients usually need oral nutrition supplements this can be higher in clinical practice and 5 of patients need tube feeding
Oral dietary supplements are widely accessible and are chosen based on the specific requirements of each patient It has been proposed that people with chronic pancreatitis benefit from the use of oral elemental supplements Oral elemental supplements have been linked to improvements in nutrition indices and a significant decrease in pain levels1819 Ito et al showed that two patients with calcified chronic pancreatitis experienced significant pain reduction when they consumed an elemental diet orally without the need for tube feeding20 In addition Shea et al examined the benefits of an oral peptide-based diet containing medium-chain triglycerides MCT on eight individuals with chronic pancreatitis demonstrating improvements in pain management21
The current investigator initiated study we hypothesize that pre-digested proteins could improve the intestinal absorption With this premise we aim to investigate the role of proteolytic enzyme fortified protein supplementation on the nutritional status of patients with chronic pancreatitis
According to international guidelines all patients should have a screening for malnutrition within 24 hours of being admitted to the hospital and those who are at risk ought to receive appropriate nutritional therapies1617 The ongoing disease process in CP increases the requirement for nutrition Most CP patients can be treated with regular diet combined with exogenous pancreatic enzyme supplements 10 to 15 of patients usually need oral nutrition supplements this can be higher in clinical practice and 5 of patients need tube feeding
Oral dietary supplements are widely accessible and are chosen based on the specific requirements of each patient It has been proposed that people with chronic pancreatitis benefit from the use of oral elemental supplements Oral elemental supplements have been linked to improvements in nutrition indices and a significant decrease in pain levels1819 Ito et al showed that two patients with calcified chronic pancreatitis experienced significant pain reduction when they consumed an elemental diet orally without the need for tube feeding20 In addition Shea et al examined the benefits of an oral peptide-based diet containing medium-chain triglycerides MCT on eight individuals with chronic pancreatitis demonstrating improvements in pain management21
The current investigator initiated study we hypothesize that pre-digested proteins could improve the intestinal absorption With this premise we aim to investigate the role of proteolytic enzyme fortified protein supplementation on the nutritional status of patients with chronic pancreatitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None