EFFECT OF VSL#3 IN PATIENTS WITH MICROSCOPIC COLITIS

Phase 2

Completed

• Conditions: Health Condition 1: null- Microscopic colitis (Lymphocytic colitis, collagenous colitis and Not otherwise sepcified colitis/ NOS)

• Registration Number: CTRI/2008/091/000086
• Lead Sponsor: CD Pharma India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Age more than or equal to 18 years

2. Collagenous or lymphocytic colitis diagnosed on colon biopsies reviewed by a GI pathologist

3. Currently symptomatic as defined by more than or equal to 3 bowel movements per day with a stool consistency more than 3 and a diarrhea severity score more than 1 averaged over the week prior to enrolment in the study

4. A syndrome present for at least 8 weeks characterized by non-bloody watery diarrhea

5. A normal endoscopic appearance of the colonic mucosa

6. Colonic histopathology (that includes involvement of distal colon) consisting of excess mononuclear inflammatory cells in the lamina propria and surface epithelium without significant neutrophilic or eosinophilic inflammation, numerous crypts abscesses, or granulomata and no other evidence of Crohn?s disease

7. Eligible patients would be included if they had no steatorrhea, had taken no antibiotics or anti-inflammatory agents for at least 6 weeks and no antidiarrheals (e.g., Loperamide) for at least 2 weeks before beginning the study

8. Negative stool culture for pathogens (Salmonella and Shigella), parasites and ova/ cyst

9. For women of child-bearing potential, had a negative pregnancy test

10. Ability to give a valid informed consent.

Exclusion Criteria

1. Unwilling or unable to give informed consent, follow protocol or to stop all medications used to treat diarrhea or colitis

2. Treatment with immunosuppressive medications or presence of an immunocompromised state

3. Other active diarrheal conditions (sprue, infection, hyperthyroidism)

4. Current infection with enteric pathogen

5. Significant hepatic, renal, endocrine (Diabetes), respiratory, neurological or cardiovascular disease as determined by the principal Investigator

6. Patient requiring hospitalization

7. Pregnancy or lactation

8. Use of any other investigational drug and/or participation in any clinical trial within 3 months of entry to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified