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

Not yet recruiting

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

Recruitment & Eligibility

Inclusion Criteria

Age between 18 â€“ 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.

Exclusion Criteria

Patients with disease activity (SCCAI â‰¥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.

Primary Outcome Measures

Name	Time	Method
1. Clinical relapse as defined by increase in SCCAI â‰¥3 for more than 7 days	1. Clinical relapse as defined by increase in SCCAI â‰¥3 for more than 7 days \| 2. Change in microbiome composition as evaluated by 16srRNA analysis
2. Change in microbiome composition as evaluated by 16srRNA analysis	1. Clinical relapse as defined by increase in SCCAI â‰¥3 for more than 7 days \| 2. Change in microbiome composition as evaluated by 16srRNA analysis

Secondary Outcome Measures

Name	Time	Method
1. Adherence to plant based diet.	2. Quality of life at 1 year as assessed by Short Inflammatory Bowel Disease

Locations (1): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Dr Vineet Ahuja
Principal investigator
9868397206
vineet.aiims@gmail.com