Efficacy and safety of Mutaflor (R) (Escherichia coli strain Nissle 1917) in patients with irritable bowel syndrome

Ardeypharm GmbH0 个研究点目标入组 120 人开始时间: 2010年5月21日最近更新: 2024年8月19日

适应症

试验速览

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•1. Age 18 - 65 years
•2. At least 12 week, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has 2 of 3 features:
•- relieved with defecation; and/or
•- Onset associated with a change in frequency of stool; and/or
•- Onset associated with a change in form (appearance) of stool (Irritable bowel syndrome confirmed according to the Rome-II-criteria)
•3. Total points in Kruis score = 26 points
•4. At least three of the following symptoms are present at entry into the study:
•diarrhoea, constipation, urgency of defecation, abdominal pain, meteorism, flatulence, tenesmus, tender on pressure, abdominal sounds, nausea, satiety. 5. Informed consent given in writing and signed

•General Exclusion Criteria:
•1. Participation in a clinical study within the last 30 days
•2. Simultaneous participation in another clinical study
•3. Lack of cooperation
•4. Limited legal capacity of patient
•5. Women of childbearing age without sufficient contraceptive protection
•6. Pregnancy or breastfeeding
•7. Dependence on alcohol, medical drugs or other drugs
•8. Severe mental disorders or depressions within the last two years
•9. Anamnestic data indicating an organic disease (red flags”) and requiring further diagnostic tests
•10. Oher reasons running counter to inclusion of the patient in the study in the investigator's view
•Anamnestic Exclusion Criteria
•1. Lack of complaints
•2. Inflammatory bowel disease
•3. Infectious colitis
•4. Carcinoma
•5. Celiac disease
•6. Intolerance of lactose
•7. Use of laxatives (i.e. regularly on at least 5 days per week)
•8. Functional diarrhoea (i.e. more than ¾ of all defecations in the last 3 months were either thick pasty, thin pasty or watery)
•9. Chronic constipation (i.e. regular need of intense pressing to achieve a painful defecation without using pharmacological, chemical or mechanical aids)
•10. Serious operation of the colon (colectomy, partial or total)
•11. Present intake of antibiotics
•12. Intake of Mutaflor within the last 3 months

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