Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.

Impact of Proteolytic Enzyme Fortified Protein Supplement in Patients With Chronic Pancreatitis.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition; Chronic Pancreatitis
• Intervention / Treatment: Dietary supplement: Proteolytic enzyme fortified protein supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radha Reddy, PhD; Phone Number: 9849423806; Email: dr.radhar@aighospitals.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • Asian Institute of Gastroenterology Hospitals
      • Contact: Rupjyoti Talukdar, MD, FICP, AGAF; Phone Number: +917032804231; Email: rup_talukdar@yahoo.com
      • Contact: Radha Reddy, PhD; Phone Number: 9849423806; Email: dr.radhar@aighospitals.com
      • Principal Investigator: Radha Reddy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group I receive 15 gms of Protein supplements (proteolytic enzyme with 70000 Hb unit tyrosine [HUT] fortified with 15 gms of whey protein), given daily for 6 weeks.	Dietary supplement: Proteolytic enzyme fortified protein supplement; Group I receive Enzotein 15 gms (proteolytic enzyme with 70000 Hb unit tyrosine (HUT) fortified with 15 gms of whey protein), given for 6 weeks. Enzotein will be provided by (Mylin Biotech India Ltd.)
Active Comparator: Group B; Group II will receive equivalent dose of plain protein supplement without proteolytic enzyme, given daily for 6 weeks.	Dietary supplement: Proteolytic enzyme fortified protein supplement; Group I receive Enzotein 15 gms (proteolytic enzyme with 70000 Hb unit tyrosine (HUT) fortified with 15 gms of whey protein), given for 6 weeks. Enzotein will be provided by (Mylin Biotech India Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	Improvement in body weight at least by 10% of the original weight.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in body composition	Change in composition in medical body composition analyser (mBCA) test	6 weeks
Improvement in body function 1	Muscle strength will be assessed by Jamar Hand grip Dynamometer at baseline and at the end of 6 weeks.	6 weeks
Improvement in body function 2	Muscle function will be assessed by SARC-F questionnaire at baseline and at the end of the 6 weeks	6 weeks
Improvement in body function 3	Muscle performance will be assessed using a 6-minute walk test at baseline and at the end of the 6 weeks	6 weeks
Improvement in pain	Improvement in pain (VAS 0-10)	6 weeks

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Rupyoti Talukdar, MD, Director, Pancreatology

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: malnutrition; randomised controlled trial; chronic pancreatitis; enzyme fortified protein supplementation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Nutrition Disorders; Pancreatic Diseases; Chronic Disease; Malnutrition; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: PEFP2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No