| CTRI Number |
CTRI/2022/03/041032 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
30/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect and tolerance of a plant based diet in reducing the flare of clinical symptoms in patients with ulcerative colitis who are asymptomatic at time of study |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate Efficacy and Tolerability of Plant Based Diet in Maintaining Remission in Patients with Ulcerative Colitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Vineet Ahuja |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr Vineet Ahuja Professor
Department of Gastroenterology and Human Nutrition All India Institute of Medical Sciences, New Delhi Phone: 09868397206, E mail: vineet.aiims@gmail.com
South
DELHI
110029
India |
| Phone |
9868397206 |
| Fax |
|
| Email |
Vineet.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Vineet Ahuja |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr Vineet Ahuja Professor
Department of Gastroenterology and Human Nutrition All India Institute of Medical Sciences, New Delhi Phone: 09868397206, E mail: vineet.aiims@gmail.com
South
DELHI
110029
India |
| Phone |
9868397206 |
| Fax |
|
| Email |
Vineet.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Vineet Ahuja |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr Vineet Ahuja Professor
Department of Gastroenterology and Human Nutrition All India Institute of Medical Sciences, New Delhi Phone: 09868397206, E mail: vineet.aiims@gmail.com
South
DELHI
110029
India |
| Phone |
9868397206 |
| Fax |
|
| Email |
Vineet.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
room no 3093, 3rd floor, teaching block, AIIMS, Ansari nagar, New Delhi. 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
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
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
| Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
plant based diet |
Patients in the intervention arm will be advised a plant based diet, which would be rich in dietary
constituents that will promote healthy microbiota and improve the intestinal barrier, and will be poor
in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier |
| Comparator Agent |
standard diet |
Patients will be asked to have normal (usual diet). Regular telephonic followup will be
done every month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 – 80 years
2. Patients with clinical remission for 3month as assessed by simple clinical colitis activity index
(SCCAI 0-2)
3. Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks
4. Patients on stable doses of azathioprine/6-mercaptopurine for past 3 months
5. Last steroid intake- 6 months prior
6. Patients giving consent for plant based diet
7. Patients who agree to adhere to the diet schedule |
|
| ExclusionCriteria |
| Details |
1. Patients with disease activity (SCCAI ≥3)
2. Patients on steroids
3. Patients who have received topical 5-ASA or topical steroids in the past 2 weeks
4. Patients with H/O of antibiotic exposure in the past 4 weeks
5. Patients requiring hospitalization
6. Patients with H/O bowel surgery
7. Patients with concomitant GI infection
8. Pregnancy
9. Patients with other co morbid illnesses
10. Patients not giving consent for plant based diet
11. Patients who disagree to adhere to the diet schedule |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days
2. Change in microbiome composition as evaluated by 16srRNA analysis |
1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days
2. Change in microbiome composition as evaluated by 16srRNA analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adherence to plant based diet.
2. Quality of life at 1 year as assessed by Short Inflammatory Bowel Disease
Questionnaire (SIBDQ) (Appendix A).
3. Patient related outcome measures (PROMs) |
1 year |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 (IBD) is rapidly emerging in the developing world including India. The interplay between genetic susceptibility and environmental risk factors is the most accredited theory in the etiopathogenesis of IBD. Diet is a key environmental factor. It plays a major role in the homeostasis of gut microbial composition, functioning and consequently the microbial metabolites. Dietary composition 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 ulcerative colitis.
In this research we are testing the is the efficacy of plant based diet (PBD) in preventing relapse in patients with ulcerative colitis in remission through its action on gut microbiome. PBD involves the foods only which are plant products and not from animal source (except fresh curd). PBD has been tested before in patients with ulcerative colitis, but studies have included hospitalized patients and some studies have shown it to be efficacious while some have not. The success depends upon the adherence to the diet and the disease activity of the patient |