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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 Syndrome
MedDRA 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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