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CTRI Number  CTRI/2020/10/028302 [Registered on: 08/10/2020] Trial Registered Prospectively
Last Modified On: 07/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Effect of digestive enzymes supplement on bacterial diversity in patients with chronic pancreatitis  
Scientific Title of Study   Role of pancreatic enzyme replacement therapy on gut microbiome, metabolome and body response in patients with chronic pancreatitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Gunjan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Room No-3111, 3rd floor, Teaching block, Department of Gastroenterology and HNU

New Delhi
DELHI
110029
India 
Phone  01126546579  
Fax    
Email  drdg_01@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Gunjan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Room No-3111, 3rd floor, Teaching block, Department of Gastroenterology and HNU

New Delhi
DELHI
110029
India 
Phone  01126546579  
Fax    
Email  drdg_01@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Deepak Gunjan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Room No-3111, 3rd floor, Teaching block, Department of Gastroenterology and HNU

New Delhi
DELHI
110029
India 
Phone  01126546579  
Fax    
Email  drdg_01@rediffmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepak Gunjan  All India Institute of Medical Sciences, Delhi  Room No-3111,3rd floor, Teaching block, Department of Gastroenterology and HNU
New Delhi
DELHI 		 9999807382

drdg_01@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
Patients  (1) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Healthy control  Standard of care 
Intervention  Pancreatic enzyme replacement therapy  Patients with chronic pancreatitis with pancreatic exocrine insufficiency will receive pancreatic enzyme replacement therapy (amylase 18,000 – 20,000,lipase 25000,protease 1,000 PEU) thrice daily with meals for three months duration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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


 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Compare gut microbiome; and fecal, serum and tissue metabolome in patients of chronic pancreatitis with and without pancreatic exocrine insufficiency with healthy controls
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  
Outcome  TimePoints 
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
3.Change in anthropometry, body composition and quality of life
 		 0 and 3 months  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 the gut microbiome, and fecal, serum and tissue metabolome in patients  of  chronic pancreatitis  without pancreatic exocrine insufficiency and patients of chronic pancreatitis with exocrine pancreatic insufficiency with healthy controls

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

(B) Secondary

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

2. To know the effect of pancreatic enzyme replacement therapy on gut-barrier and absorption function and small intestinal bacterial overgrowth (SIBO) in patients with chronic pancreatitis

3. To study the effect of pancreatic enzyme replacement therapy on anthropometric measurement, body composition and quality of life in patients with chronic pancreatitis

Bibliography

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

3.Min M, Patel B, Han S, Bocelli L, Kheder J, Vaze A, Wassef W.Exocrine Pancreatic Insufficiency andMalnutrition in Chronic Pancreatitis: Identification, Treatment, and Consequences.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.


 
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