Investigation of the efficacy of a novel galacto-oligosaccharide prebiotic (B12GOS) in the treatment of irritable bowel syndrome
| ISRCTN | ISRCTN54052375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54052375 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/10/2005
- Registration date
- 10/11/2005
- Last edited
- 17/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David B A Silk
Scientific
Scientific
Department of Gastroenterology & Nutrition
Central Middlesex Hospital
Acton Lane
London
NW10 7NS
United Kingdom
Study information
| Study design | Interventional, single blind, randomised, stratified, parallel design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Yes. Approved October 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2006 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 66 patients. |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Gastroenterology & Nutrition
London
NW10 7NS
United Kingdom
NW10 7NS
United Kingdom
Sponsor information
Clasado Ltd (UK)
Industry
Industry
11 Warren Yard
Wolverton Mill
Milton Keynes
MK12 5NW
United Kingdom
| Website | http://www.clasado.com |
|---|---|
"ROR" |
https://ror.org/04e5xac72 |
Funders
Funder type
Industry
Clasado Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2009 | Yes | No |
