Clinical trial NCT06585735: Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.
Official title: Impact of Proteolytic Enzyme Fortified Protein Supplement in Patients With Chronic Pancreatitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Malnutrition
Keywords: chronic pancreatitis
malnutrition
enzyme fortified protein supplementation
randomised controlled trial
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 disease's 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 1.2 to 1.5 g/kg protein and 25 to 35 kcal/kg 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 therapies16,17. 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 levels18,19. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with Chronic pancreatitis and on PERT.
2. Patient who has given consent for the study.
3. Participants who are greater 18yrs of age
4. Patients on oral diet
5. BMI less than ≤ 20kgs/m2

Exclusion Criteria:

1. Patients with hemodynamic instability.
2. Patients with history of GI surgeries.
3. Patients on immunosuppressants
4. Patients having other malignancies.
5. Participants who are allergic/ intolerance to any of the ingredients in the supplement
6. Patients on enteral feeding or in combination with parenteral nutrition

Primary outcomes:
measure: Weight gain
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement in body composition
timeFrame: 6 weeks
measure: Improvement in body function 1
timeFrame: 6 weeks
measure: Improvement in body function 2
timeFrame: 6 weeks
measure: Improvement in body function 3
timeFrame: 6 weeks
measure: Improvement in pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology Hospitals
state: Telangana
Study officials:
affiliation: Director, Pancreatology
name: Rupyoti Talukdar, MD
role: PRINCIPAL_INVESTIGATOR
References: