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CTRI Number  CTRI/2022/03/041033 [Registered on: 11/03/2022] Trial Registered Prospectively
Last Modified On: 10/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [plant based diet]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the effect of a plant based diet in reducing the flare of clinical symptoms and its effect on the gut bacteria in patients with Crohn’s disease who are asymptomatic at time of study  
Scientific Title of Study   Effect of plant-based diet on gut microbiome and prevention of relapse in patients with Crohn’s disease in remission: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.3093, Teaching block, third floor, AIIMS, New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone    
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.3093, Teaching block, third floor, AIIMS, New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone    
Fax    
Email  vineet.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVineet Ahuja 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.3093, Teaching block, third floor, AIIMS, New Delhi South DELHI 110029 India

South
DELHI
110029
India 
Phone    
Fax    
Email  vineet.aiims@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Room no.3093, Teaching block, third floor, AIIMS, New Delhi South DELHI 110029 India  
Type of Sponsor  Research institution and hospital 
 
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 
Dr Vineet Ahuja  AIIMS  Room no.3093, Teaching block, third floor, AIIMS, New Delhi South DELHI 110029 India
South
DELHI 		 9868397206

vineet.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K508||Crohns disease of both small andlarge intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo  Patients will be asked to have normal (usual diet) along with standard medical management. Patients will be followed every month telephonically and every 3 months physically. Dietary adherence in the experimental arm will be assessed with PBD (plant-based diet) score at regular intervals. CDAI scoring, SGA, lifestyle questionnaire, and IBD control questionnaire will be assessed at all visits. At the point of treatment failure in any arm, the patient will be withdrawn from the study and stool samples will be collected for microbiome analysis and fecal calprotectin. They will be administered appropriate treatment as per the disease activity.  
Intervention  plant based diet  Patients will be given a plant-based diet chart accordingly and will be counselled to adhere to the diet protocol. Regular telephonic interviews will be done to ensure compliance with the diet. PBD score will be measured to assess adherence to prescribed diet. Patients will be followed every month telephonically and every 3 months physically. Dietary adherence in the experimental arm will be assessed with PBD (plant-based diet) score at regular intervals. CDAI scoring, SGA, lifestyle questionnaire, and IBD control questionnaire will be assessed at all visits. At the point of treatment failure in any arm, the patient will be withdrawn from the study and stool samples will be collected for microbiome analysis and fecal calprotectin. They will be administered appropriate treatment as per the disease activity. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age between 18 – 65 years
2. Patients with Crohn’s disease with CDAI (<150), CRP <5mg/dl and FCP <150ug/gm
3. Patients with inflammatory phenotype (B1)
4. Patients who agree to adhere to the diet schedule
5. Patients on stable doses of azathioprine/ 6-mercaptoprine/ methotrexate for 6 months
6. Patients on stable doses of 5-ASA for 4 weeks 
 
ExclusionCriteria 
Details  1. Patients with severe disease activity
2. Patients with antibiotic or probiotic usage in the past 4 weeks
3. Patients with active perianal disease
4. Patients with abdominal abscess/ intestinal fistulae/ obstruction
5. Patients with symptomatic strictures
6. Patients with history of extensive colonic resection, subtotal or total colectomy7. Patients with ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
8. Patients requiring or expected to require surgical intervention
9. Patients requiring hospitalization
10. Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of plant-based diet on gut microbiome in patients with Crohn’s disease in
remission 		 Baseline, 48 weeks and during relapse 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate efficacy of plant-based diet in preventing relapse in patients with Crohn’s disease who
are in clinical and biochemical remission
2. To evaluate tolerability of plant-based diet in patients with Crohn’s disease 		 1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/03/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 ( I BD) is rapidly emerging in the developing world including in India. The interplay between genetic susceptibility and environmental risk factors is the most accredited theory in the etiopathogenesis of IIBD. Diet is a key environmental factor. It plays a major role in the homeostasis of gut microbial composition, functioning and consequently the microbial metabolities. Dietary composit ion regulates mucosal barrier function, gut immunity and gut inflammation.

Because plant based diet has a positive impact on gut microbiome and is a concept which has not been previously explored in India, forms the basis of the present study. In this study, by the intervention of plant based diet we look forward for change in gut microbiome which may lead to decrease in relapse rate in Crohn’s disease
 
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