Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.

Sponsor
Asian Institute of Gastroenterology, India
Study ID
NCT06585735
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.)

Study Details

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.

Key Dates

First listed
Sep 5, 2024
Start date
Sep 1, 2024
Status verified
Sep 2024
Primary completion
Mar 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Group B
    Group II will receive equivalent dose of plain protein supplement without proteolytic enzyme, given daily for 6 weeks.

Primary Outcome Measure

Weight gain [ Time Frame: 6 weeks ]

Central Contacts

Related Studies