| 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
|
|
|
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
|
|
|
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. |