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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004162-13-DE
Enrollment
40
Registered
2006-10-06
Start date
2007-02-27
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 8.1 Level: LLT Classification code 10021972 Term: Inflammatory bowel disease

Interventions

Trade Name: Salofalk 4g/60ml Klysma Pharmaceutical Form: Enema* INN or Proposed INN: MESALAZINE CAS Number: 89576 Current Sponsor code: Salofalk 4g/60ml Klysma Concentration unit: g/ml gram(s)/millili

Sponsors

Charité Universitätsmedizin, Campus Charité Mitte
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 = 220 and = 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

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 2x ULN.

Design outcomes

Primary

MeasureTime frame
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. To assess patients´quality of life To assess drug safety;Primary end point(s): Percentage decrease in the number of germs/ml mucus at week 4 (LOCF)—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026