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

Conditions: Health Condition 1: K861- Other chronic pancreatitis

Registration Number: CTRI/2020/12/029888

Lead Sponsor: ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 : <br/ ><br>1.Gut Microbiota <br/ ><br>2.Resting energy expenditureTimepoint: 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: <br/ ><br>a)Levels of inflammatory cytokines <br/ ><br>b)Small intestinal bacterial overgrowth <br/ ><br>c)Body composition <br/ ><br>d)Quality of lifeTimepoint: 3 months