Bacteria and host immune response as factors modulating visceral afferent processing in Irritable Bowel Syndrome: manipulation of visceral hypersensitivity with probiotic bacteria
- Conditions
- Irritable Bowel SyndromeMedDRA version: 9.1Level: LLTClassification code 10023003Term: Irritable bowel syndrome
- Registration Number
- EUCTR2007-000008-34-GB
- Lead Sponsor
- orth West London Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
The inclusion criteria are:
Patients fulfilling the Rome II criteria for the diagnosis of IBS
Normal blood investigations (FBC, ESR, CRP, LFT, RCF, Ferritin, Vitamin B12)
Normal colonoscopy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The exclusion criteria will be:
A history of weight loss
Rectal bleeding
Fevers
Psychiatric illness (severe depression, anxiety, mania and schizophrenia)
Active infection
Recent antibiotic therapy or anti-inflammatory medication within previous 4 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method