Effects of probiotics in ulcerative colitis patients

Phase 2

• Conditions: Condition 1: Ulcerative Colitis. Condition 2: Ulcerative Colitis. Condition 3: Ulcerative Colitis.; Chronic Ulcerative Proctitis; Ulcerative (chronic) rectosigmoiditis; Left sided colitis left hemicolitis

• Registration Number: IRCT201407271264N5
• Lead Sponsor: Vice chancellor for research, Golestan University of Medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Main inclusion criteria:
1-Diagnosis of ulcerative colitis established by previous colonoscopy with consistent histology and clinical course; 2-Ulcerative colitis involving at least rectosigmoid region, activity confirmed by colonoscopy prior to the study; 3- Mild-to-moderate relapsing ulcerative colitis, defined as simple clinical colitis activity; 4- Relapsing episodes for less than 4 weeks before study entry; 5- Use of oral 5-aminosalicylic acid, at least 4 weeks before study at a stable dose (mesalazine at least 1.6 g/day) or 6-mercaptopurine (at least 1 mg/kg/day) at least 3 months before study entry at a stable dose.
Main exclusion criteria:
1- Crohn's disease or pouchitis; 2- Severe ulcerative colitis according to simple clinical colitis activity index; 3- Use of oral steroids within the last 4 weeks before study entry; 4- Use of antibiotics within the last 2 weeks before study entry; 5- Change in dose of oral 5-aminosalicylic acid, within the last 4 weeks before study entry and within the 8-week study period or a change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months before the study
6- use of rectal 5-aminosalicylic acid, or steroids within 1 week before the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified