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.
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.
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
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.
- Conditions
- Chronic Pancreatitis, Malnutrition
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
Weight gain
Improvement in body weight at least by 10% of the original weight.
Measured: 6 weeks
Secondary outcomes (5)
Improvement in body composition
Change in composition in medical body composition analyser (mBCA) test
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 weeks
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.
- First posted5 Sep 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupjyoti Talukdar, Asian Institute of Gastroenterology, India
- Investigators
- Rupyoti Talukdar, MD, Principal investigator, Director, Pancreatology
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Proteolytic Enzyme Fortified Protein Supplement in Patients With Chronic Pancreatitis.
- ClinicalTrials.gov ID
- NCT06585735
- Acronym / sponsor ID
- PEFP2024
- Conditions
- Chronic Pancreatitis, Malnutrition
- Keywords
- chronic pancreatitis, malnutrition, enzyme fortified protein supplementation, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Proteolytic enzyme fortified protein supplementGroup 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. |
| Group B | Active comparator | Dietary Supplement: Proteolytic enzyme fortified protein supplementGroup II will receive equivalent dose of plain protein supplement without proteolytic enzyme, given daily for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteolytic enzyme fortified protein supplementGroup 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.) | Dietary supplement | Group A, Group B |
Primary outcome
Weight gain
Time frame: 6 weeks
Improvement in body weight at least by 10% of the original weight.
5 secondary outcomes
Improvement in body composition
Time frame: 6 weeks
Improvement in body function 1
Time frame: 6 weeks
Improvement in body function 2
Time frame: 6 weeks
Improvement in body function 3
Time frame: 6 weeks
Improvement in pain
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupyoti Talukdar, MD principal investigator
Director, Pancreatology
1 site in 1 country: see every site and its status.
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.