Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Single blind, randomised, stratified, parallel design in patients with diarrhoea predominant IBS (D-IBS), constipation predominant IBS (C-IBS) and alternating IBS (A-IBS). The single blind nature of t
Sponsors
Clasado Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients fulfilling the Rome II criteria for diagnosis of IBS will be included in the study. All will have normal haematological and biochemical indices and no abnormal findings on barium enema or colonoscopy undertaken within the previous five years. Patients will be categorised into diarrhoea predominant (D-IBS), constipation predominant (C-IBS) or altering sub groups of IBS (A-IBS) according to published criteria.
Exclusion criteria
Exclusion criteria: 1. Patients with evidence of organic disease of the gastrointestinal tract such as tumour, inflammatory bowel disease etc. as shown by endoscopic or radiological evaluation of the bowel within the previous 5 years 2. Patients with abnormal laboratory tests, positive stool cultures in patients with diarrhoea predominant IBS or abnormal proctoscopy or abdominal ultrasound which requires further investigation 3. Functional disorder of upper gastrointestinal tract for which treatment has not been stable for past three months 4. Use of other investigational drugs within prior month or intention to use such drugs during the course of the study 5. Intention to use regularly other medication or investigational agents that affect gastrointestinal motility 6. Ingestion of products containing pre- and or pro-biotics in the last two weeks before the trial commences 7. Received antibiotics in the previous three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the tolerability of B12GOS in IBS patients and to assess the B12GOS-induced changes in: 1. The faecal microbiota of patients with IBS using culture independent methodology 2. The concentration of colonic fermentation end-products (short fatty acids) in the faecal samples | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the efficacy of B12GOS versus placebo on Subjects Global Assessment of relief (SGA), severity of patient symptoms, stool frequency and consistency and quality of life. | — |
Countries
United Kingdom
Outcome results
None listed