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CTRI Number  CTRI/2020/08/027486 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 17/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To study the profile of inflammatory bowel disease (both ulcerative colitis and crohns disease) in India 
Scientific Title of Study   Clinical spectrum of Inflammatory Bowel Disease in tertiary care centre in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajit Sood 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone    
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajit Sood 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Ludhiana


PUNJAB
141001
India 
Phone    
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajit Sood 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Ludhiana


PUNJAB
141001
India 
Phone    
Fax    
Email  ajitsood10@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital Ludhiana 
Address  Dayanand Medical College and Hospital Tagore Nagar CivilLines Ludhiana 
Type of Sponsor  Private medical college 
 
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 
Ajit Sood  Dayanand Medical College and Hospital  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Ludhiana
PUNJAB 
9815400718

ajitsood10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K50||Crohns disease [regional enteritis], (2) ICD-10 Condition: K51||Ulcerative colitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with Inflammatory Bowel Disease
Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations
 
 
ExclusionCriteria 
Details  Pregnant/lactating female
History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, significant co-morbidities like advanced coronary artery disease, etc.) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical spectrum of patients with Inflammatory Bowel Disease in a tertiary care hospital in north India.  1 year, 2 years, 5 years 
 
Secondary Outcome  
Outcome  TimePoints 
To study the clinical profile of patients with IBD presenting at different ages (17 years, 17-60 years and 60 years)
To study the requirement, use and response to immunosuppressants and biologics
To study the nutritional status including sarcopenia in patients with IBD
To study the trends of IBD
 
1 year, 2 years and 5 years 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/09/2020 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

India appears to be on the epidemiological crossroads where infectious diseases as well as diseases hitherto considered to be diseases of the Western world are both being witnessed. Incidence and prevalence of IBD is increasing. The clinical spectrum of IBD in India is likely to be different from west because of differences in genetic and environmental influences. This has been partly looked into by a country-wide survey of IBD from India. IBD in the West is characterized by a bimodal age distribution with peaks at age groups 20–39 and 60–79 years. However the mean age at diagnosis of UC and CD was 38.5 and 35.9 years, respectively, in India and is not associated with a second peak. Similarly gender distribution, disease location and behavior in India are expected to be distinct from west. The long-term disease course of Indian IBD patients including need for immunosuppressives, biologics, surgical interventions and rates of complications including colorectal carcinoma needs to be studied in detail. Malnutrition is a major complication of inflammatory bowel disease (IBD). The main determinants of malnutrition in IBD include poor oral intake, malabsorption, chronically stimulated inflammatory cascade, gastrointestinal nutrient loss and increased energy expenditure. IBD can also alter the homeostasis of muscles, bones, and fat leading to sarcopenia (defined as depletion in lean muscle mass coupled with a loss of muscle strength) and dysregulated body composition. Lean mass deficits have been associated with demonstrable morbidity, mortality, and reduced quality of life. Sarcopenia is common in patients with IBD and such patients have higher rates of both surgical interventions and postoperative complications. Other particular concerns in IBD patients are that many of the patients are young, have active inflammation, may be profoundly malnourished and are immunosuppressed. Despite the risks and potential sequelae of low lean muscle mass and sarcopenia in IBD, there is a lack of high-quality data. A correct assessment of muscle mass and strength as well as nutritional status that provides quantitative and qualitative evaluations is important and timely recognition of sarcopenia/malnutrition may help in planning adequate and customized nutritional regimens. The presentation and spectrum of IBD has also changed in last two decades.

 
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