Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Irritable bowel syndrome (IBS) is the commonest functional gastrointestinal disorder. Symptoms occur in the absence of any demonstrable organic disease. Symptoms arise as a consequence of either abnormality of the intestinal motility or sensation or as a combination of the two. Abnormal small intestinal and colonic motility has been demonstrated in IBS patients. These may lead to the onset of pain as well as bloating and if the abnormal motility results in changes in intestinal transit, constipation and diarrhoea.
Hypothesis:
1. The principal research objective is to assess the tolerability of the new synthesised galacto-oligosaccharide prebiotic (B12GOS) in patients with irritable bowel syndrome (IBS), to evaluate the effect of B12GOS on the faecal microflora of patients with IBS, and to assess the effect of B12GOS on the concentration of colonic fermentation end products (short chain fatty acids) in the faecal samples of patients with IBS
2. To examine B12GOS efficacy verses placebo in IBS patients on the subjects global assessment of relief (SGA), severity of patient symptoms, stool frequency and consistency and quality of life
Ethics approval
Yes. Approved October 2005.
Study design
Interventional, single blind, randomised, stratified, parallel design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Irritable bowel syndrome
Intervention
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 the trial is in order that the placebo can be administered in each case prior to the prebiotic.
Patients randomised to 1 of 3 groups. Design will then consist of an initial 2 week baseline period followed by 2 treatment periods of 4 weeks each, separated by a 2 week 'wash out' phase. During the 1st treatment period patients will be asked to drink once daily before breakfast either 7.0 g (2 groups) or 3.5 g (one group) chocolate or banana flavoured placebo. After the 2 week 'wash out' period patients will be asked to drink once daily, before breakfast, either 7.0 g or 3.5 g of chocolate or banana flavoured B12GOS, or 7.0 g chocolate or banana flavoured placebo. On day 1 patient numbers will be assigned and stratified according to D-IBS, C-IBS, A-IBS. Randomisation table to be obtained from the internet.
Intervention type
Drug
Phase
Not Specified
Drug names
Galacto-oligosaccharide prebiotic (B12GOS)
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/02/2006
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 66 patients.
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology & Nutrition
London
NW10 7NS
United Kingdom
Sponsor information
Organisation
Clasado Ltd (UK)
Sponsor details
11 Warren Yard
Wolverton Mill
Milton Keynes
MK12 5NW
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Clasado Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19053980
Publication citations
-
Results
Silk DB, Davis A, Vulevic J, Tzortzis G, Gibson GR, Clinical trial: the effects of a trans-galactooligosaccharide prebiotic on faecal microbiota and symptoms in irritable bowel syndrome., Aliment. Pharmacol. Ther., 2009, 29, 5, 508-518, doi: 10.1111/j.1365-2036.2008.03911.x.