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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  
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 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  
Status 
Not Applicable 
 
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. 

 
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