Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000205932
Ethics application status
Approved
Date submitted
3/10/2008
Date registered
22/02/2011
Date last updated
5/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the probiotic bacterium Escherichia coli Nissle 1917 on symptom pattern and immunologic function in patients suffering from irritable bowel syndrome with diarrhoea
Scientific title
Effect of the probiotic bacterium Escherichia coli Nissle 1917 on symptom pattern and immunologic function in patients suffering from irritable bowel syndrome with diarrhoea
Secondary ID [1] 251874 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diarrhoea-predominant Irritable Bowel Syndrome 3789 0
Condition category
Condition code
Oral and Gastrointestinal 3966 3966 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Probiotic bacteria E.coli Nissle (Mutaflor) will be orally administered to the participant. 1 tablet, 100mg for 4 days and then 2 tablets, 200mg for the next 17 days.Treatment of probiotic bacteria tablet will commence post a permability test which includes a 24hr urine save.
Intervention code [1] 3505 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4870 0
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.
Timepoint [1] 4870 0
Screening, Baseline and at 3 weeks
Primary outcome [2] 258044 0
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.
Timepoint [2] 258044 0
Screening, Baseline and at 3 weeks
Secondary outcome [1] 8218 0
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
Timepoint [1] 8218 0
Baseline and at 3 weeks
Secondary outcome [2] 263622 0
Peripheral Blood Mononuclear Cells (PBMC)-mediated cytokine secretion, blood serum cytokine levels, cytokine Messenger Ribonucleic acid (mRNA) production
Timepoint [2] 263622 0
Screening, Baseline and 3 weeks
Secondary outcome [3] 263623 0
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)
Timepoint [3] 263623 0
Screening, Baseline and 3 weeks

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256677 0
Hospital
Name [1] 256677 0
Royal Adelaide Hospital
Country [1] 256677 0
Australia
Primary sponsor type
Government body
Name
Department of Health
Address
Level 13, 11 Waymouth Street
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 255964 0
Commercial sector/Industry
Name [1] 255964 0
Pharma -Zentrale GMBH
Address [1] 255964 0
Loerfeid Str 20
58313 Herdecke
Country [1] 255964 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259081 0
Royal Adelaide Hospital Human Research Ethic Committee
Ethics committee address [1] 259081 0
Ethics committee country [1] 259081 0
Australia
Date submitted for ethics approval [1] 259081 0
Approval date [1] 259081 0
11/02/2008
Ethics approval number [1] 259081 0
070226

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29003 0
Address 29003 0
Country 29003 0
Phone 29003 0
Fax 29003 0
Email 29003 0
Contact person for public queries
Name 12160 0
A/Prof Jane Andrews
Address 12160 0
Department of Gastroenterology
Royal Adelaide Hospital
Ward Q7
North Tce
Adelaide SA 5000
Country 12160 0
Australia
Phone 12160 0
+61 8 8222 5207
Fax 12160 0
Email 12160 0
jane.andrews@health.sa.gov.au
Contact person for scientific queries
Name 3088 0
A/Prof Jane Andrews
Address 3088 0
Department of Gastroenterology
Ward Q7
North Tce
Adelaide SA 5000
Country 3088 0
Australia
Phone 3088 0
+61 8 8222 5207
Fax 3088 0
Email 3088 0
jane.andrews@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.