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Potential role of enzyme replacement in acute recurrent pancreatitis.

Exocrine Pancreatic Insufficiency In Acute Recurrent Pancreatitis - Prevalence, Natural History And The Potential Role of Pancreatic Enzyme Replacement Therapy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/01/079793
Enrollment
80
Registered
2025-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Apparently children of both sexes with acute recurrent pancreatitis

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 upTimepoint: 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

MeasureTime frame
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 Timepoint: 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

Countries

India

Contacts

Public ContactShalini Gajnan Hegde

St. Johns Medical College Hospital

a.kurpad@sjri.res.in9686512233

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026