| CTRI Number |
CTRI/2021/03/032408 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of environmental factors and diet in development of colitis |
|
Scientific Title of Study
|
Impact of diet, microbiome and environmental factors on Inflammatory Bowel Disease |
| 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 |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Ludhiana 141001 |
| Address |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ajit Sood |
| Designation |
Professor |
| Affiliation |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Ludhiana 141001 |
| Address |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ajit Sood |
| Designation |
Professor |
| Affiliation |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Ludhiana 141001 |
| Address |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 |
| 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 Ludhiana |
Department of Gastroenterology Third Floor Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Ludhiana PUNJAB |
9815400718
ajitsood10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dayanand Medical College and Hospital Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals Not Suffering From Any Disease |
| Patients |
(1) ICD-10 Condition: K50||Crohns disease [regional enteritis], (2) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Control Group |
nil |
| Intervention |
IBD Group |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Inflammatory Bowel Disease
Age and Gender Matched Healthy Controls
Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Known HIV positive.
Disseminated or advanced malignancy.
Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up.
Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements.
Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study.
Inability to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of diet and environmental factors as a risk factor in development of IBD |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the microbiome profile of patients with IBD and compare it with healthy controls |
6 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
01/04/2021 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inflammatory Bowel Disease is a chronic immune mediated disorder characterized by relapsing and remitting course. The etiopathogenesis of IBD is complex and involves genetic, environmental, microbial and immunological factors working in tandem. Epidemiologic and laboratory data suggest that environmental factors (through their interaction with the host and the possible agent) play an important role in influencing the risk, presentation and natural history of the disease. The rapidity of the increase in incidence of IBD in countries where IBD was previously considered uncommon—in many cases, paralleling industrial development—also points to a potential role of environmental factors that are associated with the westernization of lifestyle. Diet is the fundamental environmental factor implicated in the pathogenesis of IBD as it is intricately involved in maintaining homeostasis of the gut, preserving the gut barrier and mucosal permeability and regulating the physiological secretion of hormones in the gastrointestinal tract. Diet is also an important determinant of gut microbial composition and host immune responses. Broadly, the dietary patterns across the world have been divided into two types: Westernized diet and Mediterranean diet. While westernized diet is predominantly animal-based diet rich in xenobiotics, carbohydrates, refined sugar and ultra-processed foods, the Mediterranean diet is commonly plant-based diet rich in fibre, fruits, vegetables, nuts, dairy and fish. High prevalence of IBD in areas consuming westernized diet suggests a possible link between the two. Although high quality and in-depth studies are lacking, it is becoming increasingly evident that westernized diets have an impact on risk as well the clinical course of IBD. A shift to westernized diet is associated with increase in pathobionts belonging to pro-inflammatory phyla Actinobacteria and proteobacteria, and decrease in anti-inflammatory genera like Faealibacterium and Roseburia. With globalization and cultural influences of western lifestyle on more traditional Indian/Oriental/Mediterranean cultures, westernized diet has overshadowed the traditional healthy diets of these regions, leading to emergence of IBD. Other environmental factors that have been studied in association with risk of development of IBD are urban residence, hygiene including availability of protected drinking water and toilet facilities, presence of cattle in the house compound, smoking, breastfeeding, pollution, use of antibiotics and NSAIDs, stress, and physical inactivity. Vast differences in the genetic makeup and environmental factors in different geographical locations make it necessary that descriptive epidemiology be studied in populations from different regions and locations. |