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
- Conditions
- Crohns disease of both small andlarge intestine,
- Registration Number
- CTRI/2022/03/041033
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
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|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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- 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.
- Patients with severe disease activity 2.
- Patients with antibiotic or probiotic usage in the past 4 weeks 3.
- 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 hospitalization 10.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate effect of plant-based diet on gut microbiome in patients with Crohn’s disease in Baseline, 48 weeks and during relapse remission Baseline, 48 weeks and during relapse
- Secondary Outcome Measures
Name Time Method 1. To evaluate efficacy of plant-based diet in preventing relapse in patients with Crohn’s disease who are in clinical and biochemical remission
Trial Locations
- Locations (1)
AIIMS
🇮🇳South, DELHI, India
AIIMS🇮🇳South, DELHI, IndiaDr Vineet AhujaPrincipal investigator9868397206vineet.aiims@gmail.com