Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients

Phase 1

• Conditions: Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.; MedDRA version: 8.1Level: LLTClassification code 10021972Term: Inflammatory bowel disease

• Registration Number: EUCTR2006-004162-13-DE
• Lead Sponsor: Charité Universitätsmedizin, Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-06
• Study Completion: 2008-08-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Signed informed conssent.
- 18-70 years of age.
- Active left-sided UC or CD with inflammation within 40 cm ab ano.
- Clinical and histological confirmed diagnosis.
- Mild to moderate disease activity:
UC: CAI >= 5 and <=10
CD: CDAI >= 220 and <=350
- Enhanced mucosal biofilm, i.e., >= 0.6x10 to the 10th germs/ml mucus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Secondary serious illness,
- Positive stool test for disease causing germs,
- Therapy with mesalazine within 4 weeks and/or antibiotisc within 12 weeks prior
baseline
- Serum creatinine > 1.5 mg/dl and creatinine clearance <60mml/min per 1.73
squaremeter
- Serum transaminases (ALT or AST) or alkaline phosphatase > 2x ULN.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the influence of mesalazine or placebo on the gut flora in IBD patients.;Secondary Objective: To assess the correlation of changes in the gut flora with the clinical efficacy of mesalazine and placebo enema.<br>To assess patients´quality of life<br>To assess drug safety;Primary end point(s): Percentage decrease in the number of germs/ml mucus at week 4 (LOCF)