K58
Conditions
Interventions
Group 1: Arm 1: Day 1 to day 4: 1 capsule Mutaflor
(corresponding to 2.5-25 EXP9 viable cells of strain E. coli Nissle 1917) daily with breakfast, day 5 to day 84 1x2 capsules Mutaflor daily with brea
Sponsors
Ardeypharm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable was the clinical course of the irritable bowel syndrome during 12 weeks treatment. Evaluation was done by using a "Global Rating Scale". At the end of every week of treatment the patient had to document the answer to the question "How content have you been with the efficacy of the medication?" in the patient diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables were stool frequence, stool consistency, urgency of defecation, pain intensity, duration of pain, frequency of pain, meteorism, flatulence and nausea (documentation in patient´s diary); percussion sound; and quality of life (evaluation was done by using a special questionnaire for patients with irritable bowel syndrome). Safety was assessed in terms of adverse events and routine vital and laboratory parameters. Tolerability was assessed by patients and investigators using a 5-point rating scale. | — |
Countries
Germany
Contacts
Public ContactWolfgang Kruis
Evangelisches Krankenhaus Köln-Kalk, Innere Abteilung
Outcome results
None listed