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CTRI Number  CTRI/2021/04/032571 [Registered on: 06/04/2021] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dietary Intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Solid food based diet for treatment of Crohns Disease 
Scientific Title of Study   Impact of individualized solid food based diet on disease activity and gut microbiome in patients with active Crohn’s 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  Dayanand Medical College and Hospital Ludhiana 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815400718  
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajit Sood 
Designation  Professor  
Affiliation  Dayanand Medical College and Hospital Ludhiana 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815400718  
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajit Sood 
Designation  Professor  
Affiliation  Dayanand Medical College and Hospital Ludhiana 
Address  Department of Gastroenterology Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana
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 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital  
Address  Dayanand Medical College and Hospital Tagore Nagar Civil Lines 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 Third Floor 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 Dayanand MEdical College and Hospital Ludhiana  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],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Solid Food Based Diet   Patients in this group will be subjected to an individualized solid food based diet (nutritionally replete, vegetarian, lactose free, gluten free) in addition to the standard pharmacotherapy. The solid food based diet will be provided in the form of seven diet plans, one per day. Additionally recipes for preparing the food items will be provided. The IBD nurse and dietician will follow the patients every day either telephonically or in-person to ensure compliance and adherence to the protocols. The disease activity (CDAI, fecal biomarkers), nutritional status (screening for nutritional deficiencies, skeletal muscle mass index, body compositin analysis, weight, body mass index), serum biochemical markers (ESR, CRP-quantitative) and gut microbiota analysis will be done at baseline and week 12. 
Comparator Agent  Standard Pharmacotherapy  Patients with CD attending gastroenterology clinic/admitted to Department of Gastroenterology will be enrolled. The diagnosis and classification of IBD will be made as per established international criteria based on combination of clinical, endoscopic, histological, radiological, and/or biochemical investigations. Detailed clinical history regarding clinical presentation (symptoms both intestinal and extra intestinal), disease duration, clinical activity, previous and concomitant medications, complications, co-morbid conditions, biochemical and microbiological assessment will be done as per standard clinical protocols. The participant will be started on standard pharmacotherapy as per the judgment and wisdom of the treating physician. The disease activity (CDAI, fecal biomarkers), nutritional status (screening for nutritional deficiencies, skeletal muscle mass index, body compositin analysis, weight, body mass index), serum biochemical markers (ESR, CRP-quantitative) and gut microbiota analysis will be done at baseline and week 12. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with active Crohn’s Disease
Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations
 
 
ExclusionCriteria 
Details  Use of antibiotics currently or during the past 1 month
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   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of solid food based diet in inducing remission in patients with active Crohn’s disease.   Week 12, Week 24  
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the efficacy of solid food based diet in inducing remission with standard pharmacotherapy and exclusive enteral nutrition  Week 12, Week 24 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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 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. 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. Historically, supplementation of nutrition has been an ad­junctive therapy for management of IBD. More recently how­ever, nutrition has been evaluated as a primary therapeutic option for management of IBD in the form of solid food based diet or exclusive or par­tial enteral nutrition. Studies on use of EEN in both pediatric and adult CD have shown encouraging results.  The effects of an individualized food-based diet (CD-TREAT), with similar composition to EEN, on the gut microbiome, inflammation, and clinical response were evaluated by Svolos and colleagues. They demonstrated that solid food based diet was equivalent to EEN in decreasing gut inflammation, tolerance and efficacy in patients with active CD. The current study aims to develop a nutritional therapy program for patients with Crohn’s disease.

 
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