| 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
|
|
|
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
|
|
|
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 adÂjunctive therapy for management of IBD. More recently howÂever, nutrition has been evaluated as a primary therapeutic option for management of IBD in the form of solid food based diet or exclusive or parÂtial 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. |