Effect of digestive enzymes supplement on bacterial diversity in patients with chronic pancreatitis

Not yet recruiting

• Conditions: Healthy; Other chronic pancreatitis,

• Registration Number: CTRI/2020/10/028302
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Chronic pancreatitis (CP) is a chronic inflammatory disease of the pancreas characterized by irreversible morphological change and typically causing pain and/or permanent loss of function(1), reduction in digestive enzyme secretion (pancreatic exocrine insufficiency) and endocrine dysfunction/diabetes (DM) (2). Pancreatic exocrine insufficiency (PEI) results in maldigestion of fat and other nutrients thereby culminating in malnutrition and metabolic abnormalities(2). There is a high prevalence of fat-soluble vitamin deficiencies, osteopathy, and malnutrition in chronic pancreatitis, which is underestimated due to a lack of effective diagnosis and suboptimal therapies for pancreatic exocrine insufficiency(3).Pancreatic exocrine insufficiency characterized by inadequate pancreatic secretion of digestive enzymes and bicarbonate, is one of the most significant complications of chronic pancreatitis, affecting >50% of diagnosed patients(4).

**Objectives**

**(A) Primary**

1. To compare thegut microbiome, and fecal, serum and tissue metabolome in patients  of chronic pancreatitis  withoutpancreatic exocrine insufficiency and patients of chronic pancreatitis withexocrine pancreatic insufficiency with healthy controls

2. To determine the effect of pancreaticenzyme replacement therapy on gut microbiome, and fecal, serum and tissue metabolomein patients of chronic pancreatitis with pancreatic exocrine insufficiency

**(B) Secondary**

1. To knowthe effect of pancreatic enzyme replacement therapy on the levels ofinflammatory cytokines in patients with chronic pancreatitis

2. To know theeffect of pancreatic enzyme replacement therapy on gut-barrier and absorption functionand small intestinal bacterial overgrowth (SIBO) in patients with chronicpancreatitis

3. To studythe effect of pancreatic enzyme replacement therapy on anthropometricmeasurement, body composition and quality of life in patients with chronicpancreatitis

**Bibliography**

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1.Duggan SN. Negotiating the complexities of exocrine and endocrine dysfunction  in chronic pancreatitis. Proc Nutr Soc. 2017 Nov;76(4):484-494.

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2. Jandhyala SM, Madhulika A, Deepika G, Rao GV, Reddy DN, Subramanyam C, Sasikala M, Talukdar R. Altered intestinal microbiota in patients with chronic pancreatitis: implications in diabetes and metabolic abnormalities. Sci Rep. 2017 Mar 3;7:43640.

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3.[Min M](https://www.ncbi.nlm.nih.gov/pubmed/?term=Min%20M%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Patel B](https://www.ncbi.nlm.nih.gov/pubmed/?term=Patel%20B%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Han S](https://www.ncbi.nlm.nih.gov/pubmed/?term=Han%20S%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Bocelli L](https://www.ncbi.nlm.nih.gov/pubmed/?term=Bocelli%20L%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Kheder J](https://www.ncbi.nlm.nih.gov/pubmed/?term=Kheder%20J%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Vaze A](https://www.ncbi.nlm.nih.gov/pubmed/?term=Vaze%20A%5BAuthor%5D&cauthor=true&cauthor_uid=30074926), [Wassef W](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wassef%20W%5BAuthor%5D&cauthor=true&cauthor_uid=30074926).Exocrine Pancreatic Insufficiency andMalnutrition in Chronic Pancreatitis: Identification, Treatment, and Consequences.[Pancreas.](https://www.ncbi.nlm.nih.gov/pubmed/30074926 "Pancreas.") 2018 Sep;47(8):1015-1018.4.  Hall TC, Garcea G, Webb MA, Al-Leswas D, Metcalfe MS, Dennison AR. The socio-economic impact of chronic pancreatitis: a systematic review. J EvalClin Pract. 2014 Jun;20(3):203-7.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-10
• Study Start: 2020-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Inclusion criteria: 1.
• 18 to 65 years 2.
• Idiopathic chronic pancreatitis with and without pancreatic exocrine insufficiency 3.
• Participants giving the consent Healthy controls: will be the relative of the patient who reside in same environment as patients 1.
• Aged 18 to 65 years 2.
• No pregnancy 3.
• No calorie restriction or other special diets 4.
• No known allergy 5.
• Not on medical treatment influencing intestinal function.

Exclusion Criteria

• 1.Medical history of immune deficiency, atopy, asthma, celiac disease, colon cancer, HIV, inflammatory bowel disease, irritable bowel syndrome, gastroenteritis, necrotizing enterocolitis, rheumatoid arthritis, metabolic or liver disease.
• 2.Pregnancy 3.Medical treatment influencing intestinal function.
• 4.Subjects received antibiotics or probiotics in last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Compare gut microbiome; and fecal, serum and tissue metabolome in patients of chronic pancreatitis with and without pancreatic exocrine insufficiency with healthy controls	0 and 3 months
2.Change in gut microbiome; and fecal, serum and tissue metabolome after pancreatic enzyme replacement therapy in patients with chronic pancreatitis with exocrine pancreatic insufficiency	0 and 3 months

Secondary Outcome Measures

Name	Time	Method
1.Change in level of inflammatory cytokines pre- and post- pancreatic enzyme replacement therapy	2.Changes in gut-barrier function pre- and post- pancreatic enzyme replacement therapy

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Delhi; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences, Delhi

🇮🇳Delhi, DELHI, India

Deepak Gunjan

Principal investigator

9999807382

drdg_01@rediffmail.com