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

Phase 4

• Conditions: K58; Irritable bowel syndrome

• Registration Number: DRKS00000416
• Lead Sponsor: Ardeypharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2002-09-28
• Study Start: 2010-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.