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

Phase 3

Completed

• Conditions: Healthy; Other chronic pancreatitis,

• Registration Number: CTRI/2020/12/029888
• Lead Sponsor: ICMR

Brief Summary

This is is an interventional study. we will see the status of and  effect of pancreatic enzyme replacement therapy on gut microbiota and resting energy expenditure in patients with chronic pancreatitis .

This study would assess the status of following parameters in patients with chronic pancreatitis versus healthy controls:-  Gut microbiota

-   Resting energy expenditure

-   Levels of inflammatory cytokines

-   Small intestinal bacterial over growth

-   Body composition

-   Quality of life

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

All India Institute Of Medical ScienceS; 🇮🇳 East, DELHI, India

All India Institute Of Medical ScienceS

🇮🇳East, DELHI, India

Sumaira Qamar

Principal investigator

09958170260

sumeira.masudi@gmail.com