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AzTrials

Chronic PancreatitisNCT06585735

Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.

A study testing Proteolytic enzyme fortified protein supplement in people with Chronic Pancreatitis and Malnutrition, run by Asian Institute of Gastroenterology, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pancreatitis, Malnutrition
What is being tested?
Proteolytic enzyme fortified protein supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndia
Study dates
1 Sep 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Radha Reddy, PhD contact

9849423806

dr.radhar@aighospitals.com

India1 site
  • Asian Institute of Gastroenterology Hospitals

    Hyderabad, Telangana, 500032

    Rupjyoti Talukdar, MD, FICP, AGAF, +917032804231, rup_talukdar@yahoo.com

    Radha Reddy, PhD, 9849423806, dr.radhar@aighospitals.com

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
Proteolytic enzyme fortified protein supplement
Keywords
chronic pancreatitis, malnutrition, enzyme fortified protein supplementation, randomised controlled trial
Medical subject headings
Pancreatitis, Chronic, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proteolytic enzyme fortified protein supplementDietary 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 groups in NCT06585735
Study groupRoleWhat they receive
Group AExperimentalGroup 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.
Receives: Dietary Supplement: Proteolytic enzyme fortified protein supplement
Group BActive comparatorGroup II will receive equivalent dose of plain protein supplement without proteolytic enzyme, given daily for 6 weeks.
Receives: Dietary Supplement: Proteolytic enzyme fortified protein supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight gain

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

    Measured: 6 weeks

Secondary outcomes (5)
  1. Improvement in body composition

    Change in composition in medical body composition analyser (mBCA) test

    Measured: 6 weeks

  2. Improvement in body function 1

    Muscle strength will be assessed by Jamar Hand grip Dynamometer at baseline and at the end of 6 weeks.

    Measured: 6 weeks

  3. Improvement in body function 2

    Muscle function will be assessed by SARC-F questionnaire at baseline and at the end of the 6 weeks

    Measured: 6 weeks

  4. 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

    Measured: 6 weeks

  5. Improvement in pain

    Improvement in pain (VAS 0-10)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585735
Sponsor's protocol ID
PEFP2024
Status last verified
Sep 2024
First submitted
18 Aug 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Proteolytic enzyme fortified protein supplement in people with Chronic Pancreatitis and Malnutrition, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Radha Reddy, PhD (9849423806, dr.radhar@aighospitals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight gain (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

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