| CTRI Number |
CTRI/2020/12/029888 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Status and effect of pancreatic enzymes on intestinal health and energy spent at rest in patients with chronic pancreatitis as compared to healthy controls |
|
Scientific Title of Study
|
status and effect of pancreatic enzyme replacement therapy on gut microbiota and resting energy expenditure 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 |
Sumaira Qamar |
| Designation |
PhD scholar |
| Affiliation |
AIIMS |
| Address |
Room No. 3068 Teaching block AIIMS, New Delhi
Room No.3068 Teaching block AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09958170260 |
| Fax |
|
| Email |
sumaira.masudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anoop Saraya |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room NO. 3111
Gastro office
Teaching block
AIIMS, New Delhi
Room NO.3111
Gastro office
Teaching block AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717830982 |
| Fax |
|
| Email |
ansaraya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anoop Saraya |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room NO. 3111
Gastro office
Teaching block
AIIMS, New Delhi
Room NO.3111
Gastro office
Teaching block AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717830982 |
| Fax |
|
| Email |
ansaraya@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sumaira Qamar |
All India Institute Of Medical ScienceS |
DEPARTMENT OF GASTROENTEROLOGY AND HUMAN NUTRITION UNIT
ROOM NO 3068 3RD FLOOR TEACHING BLOCK
AIIMS,New Delhi
East
DELHI |
09958170260
sumeira.masudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
NIL |
NIL |
| Intervention |
Pancreatic Enzyme Replacement Therapy(PERT) |
Patients with chronic pancreatitis with pancreatic exocrine insufficiency will receive pancreatic enzyme replacement therapy in dose (amylase 18,000 – 20,000,lipase 25000,protease 1,000 PEU) thrice daily during meals for three months duration. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This section would assess the status effect of following parameters in patients with chronic pancreatitis on :
1.Gut Microbiota
2.Resting energy expenditure |
0 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
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