A PROBIOTIC PREPARATION, VSL#3, FOR THE TREATMENT OF MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS

Phase 3

Completed

• Conditions: Health Condition 1: null- Patients with mild to moderately active Ulcerative Colitis

• Registration Number: CTRI/2008/091/000076
• Lead Sponsor: CD Pharma India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1.Males and females aged greater than 18 years.

2.Ulcerative colitis extending for more than 15 cm from the anal verge that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by endoscopy at the beginning of the study.

3.Diagnosis of ulcerative colitis established by previous endoscopy, with consistent histology and clinical course.

4.At least one previous episode of colitis, prior to the current episode.

5.Mild to moderately active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index? see table 1) that measures stool frequency, rectal bleeding, endoscopic findings and physicians overall assessment of disease severity (30-32).

6.Minimum sigmoidoscopic score of 2 on the UCDAI

7.Stool to be taken for culture and microscopy at inclusion. Stools to be assessed by culture for bacterial pathogens (for shigella, salmonella, campylobacter, yersenia), assessed for Cl. Difficile toxin assay, and ova and parasite exam undertaken. This must be checked at the latest by day 7 after entry (preferably at inclusion). Patient must be withdrawn if any of these results is positive (except for E.coli).

8.Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study.

9.Ability to give a valid informed consent.

Exclusion Criteria

1.Crohns disease or pouchitis

2.Current infection with enteric pathogen

3.Use of oral steroids within the last 4 weeks

4.Use of antibiotics within the last two weeks

5.Change in dose of oral 5 ASA products within the last 4 weeks

6.Change in dose of rectal 5-ASA or steroids within 7 days prior to study entry.

7.Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal Investigator

8.Imminent need for surgery or presence of severe disease (UCDAI of greater than 8)

9.Patient requiring hospitalisation

10.Pregnancy or lactation

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

12.Inability to give a valid informed consent or to properly follow the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Improvement in activity of active ulcerative colitis. This is defined as a decrease in the UCDAI of 50% or more, from baseline to week 6.Timepoint: 6 weeks

Secondary Outcome Measures

Name	Time	Method
â?¢ Improvement in activity of active ulcerativecolitis. This is defined as a decrease in the UCDAI of 3 points or more, from baseline to week 12. â?¢ Remission (defined by a UCDAI score of 0 to 2) after 12 weeks of treatment. â?¢ Change in subjective symptoms (rectal bleeding and stool frequency) from baseline to weeks 6 and 12 of treatment. â?¢ Lack of improvement at the end of 6 weeks will be considered as treatment failure. Failure to decrease of UCDAI score by 3 points or at least 50% of baseline UCDAI score at the end of 6 weeks will also be considered as treatment failure. â?¢ Time to withdrawal. <br><br><br><br><br>Timepoint: At 6 and 12 weeks