Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.

NCT06585735 | Not Yet Recruiting DMC

• 1 other identifier: PEFP2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Malnutrition

Keywords

chronic pancreatitis; malnutrition; enzyme fortified protein supplementation; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Weight gain

  Improvement in body weight at least by 10% of the original weight.

  6 weeks

Secondary Outcomes (5)

• Improvement in body composition

  6 weeks

• Improvement in body function 1

  6 weeks

• Improvement in body function 2

  6 weeks

• Improvement in body function 3

  6 weeks

• Improvement in pain

  6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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 B

ACTIVE COMPARATOR

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

Interventions

Proteolytic enzyme fortified protein supplement DIETARY_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.)

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, 500032, India

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Malnutrition

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rupyoti Talukdar, MD

  Director, Pancreatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radha Reddy, PhD

CONTACT

9849423806; dr.radhar@aighospitals.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rupjyoti Talukdar

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 5, 2024
• Study Start: September 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

IN (1)