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CTRI Number  CTRI/2025/01/079793 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Potential role of enzyme replacement in acute recurrent pancreatitis. 
Scientific Title of Study   Exocrine Pancreatic Insufficiency In Acute Recurrent Pancreatitis - Prevalence, Natural History And The Potential Role of Pancreatic Enzyme Replacement Therapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Gajnan Hegde 
Designation  Associate Professor 
Affiliation  St. Johns Medical College Hospital  
Address  Department of Pediatric Surgery 2nd floor, extension block, St. Johns Medical College Hospital Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  9914208942  
Fax    
Email  Shal.hegde@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anura V Kurpad 
Designation  Professor 
Affiliation  St. Johns Medical College Hospital  
Address  Department of Physiology, St. Johns Medical College, Bangalore; 560034, Karnataka, India Department of Physiology, St. Johns Medical College, Bangalore; 560034, Karnataka, India Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9686512233  
Fax    
Email  a.kurpad@sjri.res.in   
 
Details of Contact Person
Public Query
 
Name  Shalini Gajnan Hegde 
Designation  Associate Professor 
Affiliation  St. Johns Medical College Hospital  
Address  Department of Pediatric Surgery 2nd floor, extension block, St. Johns Medical College Hospital Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  9914208942  
Fax    
Email  Shal.hegde@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V.Ramanlingaswamy Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V.Ramanlingaswamy Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalini Hegde  St. Johns Medical College Hospital   Department of Pediatric Surgery 2nd floor, extension block, St. Johns Medical College Hospital Koramangala
Bangalore
KARNATAKA 
9914208942

Shal.hegde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Apparently children of both sexes with acute recurrent pancreatitis 
 
ExclusionCriteria 
Details  1.Associated liver disorders
2.concurrent use of pancreatic enzymes,
3.cholestasis
4.diagnosed inflammatory bowel disease,
5.Diagnosed celiac disease or small bowel malabsorption
6.previous surgical intervention on the gastrointestinal tract,
7.clinical suspicion of cystic fibrosis based on history of chronic respiratory disease/recurrent lung infection and/or family history.
8.Any major illness over the last 3 months
9.Gastroenteritis in the last 1 month
10.Drugs that affect intestinal motility in the last 1 month
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of EPI in a cohort of children with acute recurrent pancreatitis as measured by the 13C MTG breath test either at diagnosis or in follow up  Breathes samples collected every 30 minutes for 6 hours. At the 3rd hour CO2 production measured. At 4th hour a light meal consisting of 75g of fermented legume and rice along with 25g chutney sauce given. Subsequently breath test will be repeated for 2,4 and 6 months.pancreatitis as measured by the 13C MTG breath test either at diagnosis or in follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the duration of recovery of EPI in ARP following an acute episode using repeated measures of the 13C MTG breath test at 2,4 and 6 months
2.To assess change in nutritional status after 12 months of PERT in children with ARP compared to baseline
3.To develop a clinical investigation to measure EPI in children using stable isotopes which is as accurate but shorter than the standard test of 6 hrs
 
Breathes samples collected every 30 minutes for 6 hours. At the 3rd hour CO2 production measured. At 4th hour a light meal consisting of 75g of fermented legume and rice along with 25g chutney sauce given. Subsequently breath test will be repeated for 2,4 and 6 months  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: Inflammation of the pancreas (or pancreatitis) is a common but under-studied gastrointestinal condition in South Asian children. The clinical spectrum ranges from mild self-limiting abdominal pain to morbidity from peripancreatic fluid collections, recurrent admission, multi-organ dysfunction as well as long term morbidity and growth faltering from exocrine pancreatic insufficiency (EPI), diabetes mellitus and pancreatic cancer. The risk of malnutrition is especially true for children who may be in an active pubertal growth spurt (with higher nutrient requirements) during the illness, making them vulnerable to specific nutrient deficiency, metabolic bone disease and chronic growth faltering.  An additional aspect that may contribute to nutritional risk in these children is the presence of EPI. EPI is a well-known consequence of chronic pancreatitis in children and adults. However, EPI following acute pancreatitis (AP) is insufficiently acknowledged and there is emerging evidence that it is not uncommon in adults. Two recent reviews of adults with AP at the time of hospitalization, revealed EPI in majority (62%), which reduced to 35% on follow up, with some patients requiring exogenous pancreatic enzyme replacement therapy (PERT) to alleviate symptoms. The time to recovery of EPI has been reported to be variable, ranging from 1 month to many years. The studies referred to above are in reference to an adult population, there are no studies assessing whether EPI exists in the paediatric population with AP. The incidence of childhood AP is not trivial; the worldwide incidence of AP ranges between 3.6-13.2 per 100,000 per year in children <18years old. Objective: To determine the prevalence of EPI in a cohort of children with acute recurrent pancreatitis as measured by the 13C MTG breath test either at diagnosis or in follow upMethodology The day for the experiment will be taken as the second day of starting soft diet in an admitted child with ARP or as mutually decided for an OPD basis child of ARP.  On the day of the experiment, the recruited participant will arrive at 7:00 AM to the Clinical Research Centre in St Johns Medical College after an overnight fast of 8-10 hours. The weight ,height and questionnaires with respect to epidemiology data, socioeconomic status and clinical history will be recorded.Blood sample (10 ml) will be collected in a prelabelled EDTA vial, plasma will be separated after centrifugation and stored in a -80°C freezer. Stool samples will be collected freshly and sent for fecal elastase levels to ensure sample integrity. An initial basal breath sample will be collected in a modified breath bag and transferred into 10 mL glass exetainers.A meal consisting of wheat bread (50 g) and butter (10 g) sandwiches with 300 mg of  13C-MTG will be administered along with 200 ml of water.Breath samples will thereafter be collected in duplicate every 30 mins until 6 hrs. The glass exetainers containing the breath samples will be stored at room temperature until further analysis. At 3rd hr of protocol, carbon dioxide production (VCO2) will be measured for each participant using Indirect Calorimetry (IC). The protocol for IC will be explained prior so that the participant is free from emotional stress and familiar with the apparatus used. VCO2 will be measured by a ventilated hood design, where a transparent and well-ventilated canopy will be placed over the participants head in the supine position. Participants will be allowed to try on the ventilated hood for 5 mins if they wish toAt 4th hr of protocol a light meal consisting of 75 g of a fermented legume and rice preparation (idly) and 25 g of coconut sauce (chutney) will be administered to all participants.The ratio of 13CO2 to 12CO2 in the sample will be calculated after comparison with the known ratio of an external 13CO2 standard that is based on the PDB standard for 13C. The atom % excess of 13CO2 for each time point, in breath samples will be used to determine the cumulative percentage dose recovery for 13C-MTG.In a subset of case participants, 13C-MTG breath tests will be repeated at 2,4 and 6 months    to assess for spontaneous recovery of EPI with time.


 
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