| 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
|
|
|
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
|
|
|
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
|
|
|
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. |