MedDRA - 10036774/10036789: active proctitis/proctosigmoiditis K51.2 K51.3
Conditions
Interventions
Group 1: 10ml-Mutaflor-enema /
application daily in the evening /
treatment period: 4 - 8 weeks
1 ml of Mutaflor-enema contains biomass with 10exp8 viable bacteria, E. coli strain Nissle 1917
Group 2
Sponsors
Ardeypharm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Acute idiopathic proctitis/proctosigmoiditis with light to moderate disease activity. Definition of active disease: - Disease Activity Index (DAI) according to Sutherland: 4 - 9. - Definition of proctitis: Inflammation beginning at the anus up to <=15 cm. - Definition of proctosigmoiditis: Inflammation beginning at the anus to end of colon sigmoideum (about 25 - 30 cm from anus). No endoscopic or histological signs of inflammation beyond that point. - Age 18 - 70 years. - At least two manifestations of the disease (confirmed diagnosis). - Written volunteer informed consent form.
Exclusion criteria
Exclusion criteria: - Other causes of acute proctitis/proctosigmoiditis: infection, medical drugs, radiation, ischaemia of affect intestinal segment, - Crohn's disease. - History of stool incontinence. - Perianal fistulae. - Major colon surgery (colectomy, partial or total). - Colorectal carcinoma. - Colon stenoses. - Intake of Mutaflor capsules or suspension less than 4 weeks before start of the study or during the study. - Rectal treatment with steroids (absorbable or non-absorbable) or aminosalicylates within 2 weeks prior to inclusion in the study. - Intake of immunosuppressants less than 90 days before inclusion in study. - Severe accompanying diseases: - Cardiac diseases (coronary heart disease, cardiac infarction, angina pectoris, cardiac insufficiency, NYHA III - IV). - Liver diseases (cirrhosis, acute or soon after hepatitis, proliferative chronic liver disease). - Renal diseases (creatinine value outside reference range). - Other severe chronic or terminal diseases (e.g. cancer, tuberculosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary traget: Clinical remission / Method: To describe the objective target criterion, a "clinical DAI" is defined comprising the parameters "stool frequency", "rectal bleeding" and "assessment of disease activity by physician" according to Sutherland / Determined after 2, 4 and 8 weeks Response: DAI < 2 after 4 and 8 weeks, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to remission. - Changes in clinical, endoscopic and histological findings in the course of the study. - Subjective assessment of efficacy in a global assessment of health status by the patient and the Investigator. - Assessment of tolerance and practicability of the treatment by the patient. | — |
Countries
Germany
Contacts
Public ContactHarald Matthes
Gemeinschaftskrankenhaus Havelhöhe
Outcome results
None listed