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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

Not yet recruiting
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
To evaluate effect of plant-based diet on gut microbiome in patients with Crohn’s disease inBaseline, 48 weeks and during relapse
remissionBaseline, 48 weeks and during relapse
Secondary Outcome Measures
NameTimeMethod
1. To evaluate efficacy of plant-based diet in preventing relapse in patients with Crohn’s disease whoare in clinical and biochemical remission

Trial Locations

Locations (1)

AIIMS

🇮🇳

South, DELHI, India

AIIMS
🇮🇳South, DELHI, India
Dr Vineet Ahuja
Principal investigator
9868397206
vineet.aiims@gmail.com

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