How changing diet by cutting out specific foods affects the symptoms and gut bacteria in people dealing with ulcerative colitis

Not Applicable

Completed

• Conditions: lcerative colitis; Digestive System

• Registration Number: ISRCTN15559229
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-10
• Study Start: 2024-03-11
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients who are confirmed cases of mild to moderate ulcerative colitis
2. Age: 18 – 70 years of either gender
3. Patients on stable dose of mesalamine for past 4 weeks
4. Patients on stable dose of azathioprine/6-mercaptopurine for past 6 months
5. Patients on stable doses of topical therapy for past 2 weeks
6. Patients who are willing to participate

Exclusion Criteria

1. Received oral steroids in the past 4 weeks
2. Received oral antibiotics within past 2 weeks
3. Patients with severe disease activity
4. Patients with fulminant colitis requiring hospitalization
5. Patients who have had surgery
6. Patients with concomitant GI infection
7. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded
8. Pregnant, lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of clinical remission (assessed by simple clinical colitis activity index (SCCAI)=2) and faecal calprotectin <150ug/gm at 4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Change in microbiome at 4 weeks after partial enteral nutrition (PEN) and exclusion diet in the intervention arm<br>2. Proportion of patients with rectal bleeding score of 0 and stool frequency score of =1 at 4 weeks<br>3. Tolerability of PEN + exclusion diet at 4 weeks