Effect of the probiotic bacterium Escherichia coli Nissle 1917 on symptom pattern and immunologic function in patients suffering from irritable bowel syndrome with diarrhoea
Completed
- Conditions
- Diarrhoea-predominant Irritable Bowel SyndromeOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12611000205932
- Lead Sponsor
- Department of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
symptoms consistent with diarrhoea predominant IBS according to the Rome III criteria;not received antibiotics 4 weeks prior ;not taking immunosuppressive medication;not taking laxatives and prokinetic drugs for 2 weeks;able to sign consent;
Exclusion Criteria
Eligible Particpants will be deemed healthy unless they have the following..previous abdominal or gynaecologyical surgery (except appendectomy and cholecystectomy); previous gastrointestinal cancer;history of other diseases known to affect colonic motility; known peptic ulcer disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the improvement of symptoms in partcipants suffering from Diarrhoea predominant Irritable Bowel Syndromes (D-IBS) during treatment with the Escherichia coli Nissle 1917 (EcN) (Mutaflor) measured with previously standardised questionnaires.[Screening, Baseline and at 3 weeks];Assess improvement of quality of life with participants suffering from Diarrhoea predominant Irritable Bowel Symptoms during treatment with the Escherichia coli Nissle 1917 (EcN) (Mutaflor) measured with previously standardised questionnaires.[Screening, Baseline and at 3 weeks]
- Secondary Outcome Measures
Name Time Method The effect of the treatment on intestinal and colonic permeability. This will be measured via a permabiliy test which includes a 24 hour urine save[Baseline and at 3 weeks];Peripheral Blood Mononuclear Cells (PBMC)-mediated cytokine secretion, blood serum cytokine levels, cytokine Messenger Ribonucleic acid (mRNA) production[Screening, Baseline and 3 weeks];Questionnaires:- Stress Questionnaire , Hospital Anxiety and Depresson Score, Irritable Bowel Syndrome Quality of Life (IBSQoL), Bowel Disease Questionnaire (BDQ) Rome II and Rome III, Irritable Bowel Syndrome Symptom Score(IBSS)[Screening, Baseline and 3 weeks]