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Status and effect of pancreatic enzymes on intestinal health and energy spent at rest in patients with chronic pancreatitis as compared to healthy controls

status and effect of pancreatic enzyme replacement therapy on gut microbiota and resting energy expenditure in patients with chronic pancreatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029888
Enrollment
90
Registered
2020-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: K861- Other chronic pancreatitis

Interventions

Intervention1: Pancreatic Enzyme Replacement Therapy(PERT): Patients with chronic pancreatitis with pancreatic exocrine insufficiency will receive pancreatic enzyme replacement therapy in dose (amylas

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients : 1.Idiopathic chronic pancreatitis 2.With or without pancreatic exocrine insufficiency 3.Participants giving the consent Healthy Controls: 1.Relative of the patient 2.In good general health with no co morbidities(diabetes, IBD, IBS etc) 3.No pregnancy 4.No calorie restriction or other special diets 5.No known allergy 6.Not on medical treatment influencing intestinal function 7.No alcohol ( intake more than 2 pegs a day) 8.No smoking

Exclusion criteria

Exclusion criteria: 1.Concomitant medical disorder which are supposed to influence the gut microbiota like HIV, any malignancy, inflammatory bowel disease, irritable bowel syndrome, gastroenteritis, liver disease. 2.Pregnancy 3.Medical treatment influencing intestinal function 4.Subjects received antibiotics in last 3 months 5.Patients who are taking proton pump inhibitor 6.Chronic pancreatitis with another complication( symptomatic pseudocyst or GI bleed) 7.Severe pain score:16 or more

Design outcomes

Primary

MeasureTime frame
This section would assess the status effect of following parameters in patients with chronic pancreatitis on : 1.Gut Microbiota 2.Resting energy expenditureTimepoint: 0 month and 3 months

Secondary

MeasureTime frame
To determine the effect of 3 months pancreatic enzyme replacement therapy in patients with chronic pancreatitis with pancreatic exocrine insufficiency on: a)Levels of inflammatory cytokines b)Small intestinal bacterial overgrowth c)Body composition d)Quality of lifeTimepoint: 3 months

Countries

India

Contacts

Public ContactAnoop Saraya

All India Institute of Medical Sciences

ansaraya@yahoo.com9717830982

Outcome results

None listed

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