Acute Pancreatitis NecrotizingPhase 3PERT-ANPNCT07211568
PERT in Acute Necrotizing Pancreatitis
A Phase 3 study testing Pancreatic Enzyme Replacement Therapy in people with Acute Pancreatitis Necrotizing and Nutrition Assessment, run by Asian Institute of Gastroenterology, India.
Trial summary
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Pancreatitis Necrotizing, Nutrition Assessment
- What is being tested?
- Pancreatic Enzyme Replacement Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria
- Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening
- Within 28 days of onset of disease
- Age 18-60 years
- Both genders
Who cannot join
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
- Inability to give informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Pancreatic Enzyme Replacement Therapy on Nutrition in Acute Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial.
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with >50% pancreatic parenchymal necrosis and >10% loss of body weight.
The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
Read the detailed description
Acute pancreatitis (AP), an inflammatory disorder of the pancreas, is mild and self-limiting in most patients. Around 10-20% of AP patients develop acute necrotizing pancreatitis (ANP) which is characterized by destruction of both pancreatic and peripancreatic tissue and is associated with high rate of morbidity and mortality due to both local and systemic complications1,2,3.
Early recognition and close monitoring of affected patients is crucial. Treatment consists of goal-directed intravenous fluid resuscitation, pain control, and enteral nutrition as early as possible. While sterile necrosis might resolve with above conservative measures, infected necrosis requires antibiotics and further interventions such as percutaneous drainage, minimally invasive surgeries, and endoscopic necrosectomy4.
In ANP patients there is direct destruction of acinar tissue that results in pancreatic exocrine insufficiency (PEI). In PEI there is insufficient secretion of pancreatic enzymes that causes inadequate nutrient digestion and absorption resulting in weight loss, malnutrition, metabolic bone disease and fat-soluble vitamins and mineral deficiencies5. The risk of PEI after ANP is about 25% over 3 years6. According to two meta-analysis5,7, PEI was found to be more prevalent during the index AP episode and it remained persistent in about half of the study population at follow-ups. They also reported that the risk of developing PEI is more in those with alcoholic etiology and severe and necrotizing pancreatitis.
Hence, management of PEI following ANP is important to improve nutritional status and quality of life. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment for PEI. While the use of PERT is well-established in chronic pancreatitis, its efficacy in patients with ANP is still unclear. Hence, in this study, we aim to provide insights into the potential benefits of enzyme supplementation in patients with ANP by evaluating nutritional status, clinical outcomes, and quality of life.
This is a multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with >50% pancreatic parenchymal necrosis and >10% loss of body weight.
The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
- Being tested
- Pancreatic Enzyme Replacement Therapy, Placebo
- Keywords
- Nutrition in AP, PERT in AP, pancreatic exocrine insufficiency
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Enzyme Replacement TherapyDrug
Enteric coated pancreatic enzyme preparation
PlaceboDrug
Similar appearing glucose capsules
| Study group | Role | What they receive |
|---|---|---|
| PERT | Experimental | Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with food (Breakfast, lunch and dinner) Receives: Drug: Pancreatic Enzyme Replacement Therapy |
| Placebo | Placebo comparator | Similar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
BMI will be measured at baseline and again at 3 months follow-up, with the difference between the two time points used to assess the effect of the intervention on patients' weight status.
Measured: 3 months
Secondary outcomes (10)
1. Change in Quality of Life
Quality of life will be assessed by the Short Form (SF)-36 tool. The lowest score in this tool is 0 and the highest score is 100, a higher score indicating better quality of life.
Measured: 3 months
Change in pancreatic exocrine function
Exocrine function will be assessed by the Fecal elastase test.
Measured: 3 months
Change in nutritional status: Anthropometry
Skin fold thickness over the triceps muscle at the mid arm level.
Measured: 3 months
Change in nutritional status: Anthropometry
Mid-arm circumference
Measured: 3 months
Change in nutritional status: Biochemical assessment
Serum prealbumin levels (gm/dL)
Measured: 3 months
Change in nutritional status: Biochemical assessment
Serum vitamin D levels
Measured: 3 months
Change in nutritional status: Biochemical assessment
Serum vitamin B12 levels
Measured: 3 months
Change in the endocrine status
HbA1c and C-peptide
Measured: 3 months
Change in patient's impression of change after treatment
This will be evaluated using the Patient's Global Impression of Change (PGIC). The score ranges from 1-7, with a score of 1 indicating very much improved and 7 indicating very much worse.
Measured: 3 months
Readmission after onset of treatment
Readmission to hospital
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis NecrotizingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupjyoti Talukdar, MD, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211568
- Sponsor's protocol ID
- ANP-PERT 1
- Acronym
- PERT-ANP
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.
PubMed 31161524Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.
PubMed 27619808Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
PubMed 31138897Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.
PubMed 19322914Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pancreatic Enzyme Replacement Therapy on Nutrition in Acute Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT07211568
- Acronym / sponsor ID
- PERT-ANP / ANP-PERT 1
- Keywords
- Nutrition in AP, PERT in AP, pancreatic exocrine insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with >50% pancreatic parenchymal necrosis and >10% loss of body weight.
The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
Detailed description
Acute pancreatitis (AP), an inflammatory disorder of the pancreas, is mild and self-limiting in most patients. Around 10-20% of AP patients develop acute necrotizing pancreatitis (ANP) which is characterized by destruction of both pancreatic and peripancreatic tissue and is associated with high rate of morbidity and mortality due to both local and systemic complications1,2,3.
Early recognition and close monitoring of affected patients is crucial. Treatment consists of goal-directed intravenous fluid resuscitation, pain control, and enteral nutrition as early as possible. While sterile necrosis might resolve with above conservative measures, infected necrosis requires antibiotics and further interventions such as percutaneous drainage, minimally invasive surgeries, and endoscopic necrosectomy4.
In ANP patients there is direct destruction of acinar tissue that results in pancreatic exocrine insufficiency (PEI). In PEI there is insufficient secretion of pancreatic enzymes that causes inadequate nutrient digestion and absorption resulting in weight loss, malnutrition, metabolic bone disease and fat-soluble vitamins and mineral deficiencies5. The risk of PEI after ANP is about 25% over 3 years6. According to two meta-analysis5,7, PEI was found to be more prevalent during the index AP episode and it remained persistent in about half of the study population at follow-ups. They also reported that the risk of developing PEI is more in those with alcoholic etiology and severe and necrotizing pancreatitis.
Hence, management of PEI following ANP is important to improve nutritional status and quality of life. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment for PEI. While the use of PERT is well-established in chronic pancreatitis, its efficacy in patients with ANP is still unclear. Hence, in this study, we aim to provide insights into the potential benefits of enzyme supplementation in patients with ANP by evaluating nutritional status, clinical outcomes, and quality of life.
This is a multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with >50% pancreatic parenchymal necrosis and >10% loss of body weight.
The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
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 |
|---|---|---|
| PERT | Experimental | Drug: Pancreatic Enzyme Replacement TherapyEnteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with food (Breakfast, lunch and dinner) |
| Placebo | Placebo comparator | Drug: PlaceboSimilar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria
- Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening
- Within 28 days of onset of disease
- Age 18-60 years
- Both genders
Key exclusion criteria (6 listed)
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
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 |
|---|---|---|
| Pancreatic Enzyme Replacement TherapyEnteric coated pancreatic enzyme preparation | Drug | PERT |
| PlaceboSimilar appearing glucose capsules | Drug | Placebo |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: 3 months
BMI will be measured at baseline and again at 3 months follow-up, with the difference between the two time points used to assess the effect of the intervention on patients' weight status.
10 secondary outcomes
1. Change in Quality of Life
Time frame: 3 months
Change in pancreatic exocrine function
Time frame: 3 months
Change in nutritional status: Anthropometry
Time frame: 3 months
Change in nutritional status: Anthropometry
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in the endocrine status
Time frame: 3 months
Change in patient's impression of change after treatment
Time frame: 3 months
Readmission after onset of treatment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Background: PubMed 31161524Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.
- Background: PubMed 27619808Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.
- Background: PubMed 31138897Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
- Background: PubMed 19322914Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Individual participant dataSharing planned: Undecided
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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.
Rupjyoti Talukdar, MD study director
Asian Institute of Gastroenterology, India
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pancreatic Enzyme Replacement Therapy in people with Acute Pancreatitis Necrotizing and Nutrition Assessment, run by Asian Institute of Gastroenterology, 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: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdul Rasheed, PharmD (+919652104726, abdulrasheedmd1223@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211568, which also lists 5 linked publications.
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 8 Oct 2025.