Effect of potassium rich diet in patients with ulcerative colitis

Phase 4

Conditions: Health Condition 1: K638- Other specified diseases of intestine

Registration Number: CTRI/2019/03/018217

Lead Sponsor: Dept of Gastroenterology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients who are confirmed cases of mild ulcerative colitis (of any disease extent) as assessed by Mayo score (4-6), within 1 week of relapse

2.Age: 18 â?? 70 years of either gender

3.Patients on stable dose of mesalamine for past 4 weeks

4.Patients on stable dose of azathiopurine/ 6-mercaptopurine for past 6 months

5.Ready to participate

Exclusion Criteria

1.H/O of oral steroids in the past 4 weeks

2.H/O or oral antibiotics within past 2 weeks

3.H/O topical therapy within 1 week

4.Patients with severe disease activity

5.Patients with fulminant colitis requiring hospitalization

6.Patients who have had surgery

7.Patients with Crohnâ??s colitis

8.Patients with concomitant GI infection

9.Patients on drugs that can affect potassium homeostasis (ACE-inhibitors, angiotensin receptor blockers, aldosterone antagonists)

10.Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease or any other condition which precludes high potassium diet

11.Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded

12.Pregnant, lactating females

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Clinical remission at 8 weeks, defined as Mayo score â?¤2 with all sub-scores â?¤1.Timepoint: at 8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Clinical response at 8 weeks, defined as reduction in Mayo score by more than 3 points or by 30 percent reduction in Mayo score from baseline. <br/ ><br>2.Treatment failure, defined as increase in Mayo score by more than 3 points with all sub scores more than 1. <br/ ><br>3.Adverse events at 8 weeks <br/ ><br>Timepoint: At 8 weeks