EGIS V1.2 22Feb2021
Research type
Research Study
Full title
A Multi-Centre,Randomized, Placebo-Controlled, Efficacy Study of Prebiotic Galacto-oligosaccharides on Gastrointestinal Symptom Severity in Patients with Irritable Bowel Syndrome (A prebiotic dietary supplement trial)
IRAS ID
294258
Contact name
Qasim Aziz
Contact email
Sponsor organisation
Clasado Research Services Ltd
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This study has been designed by Clasado Research Services Ltd and will be conducted by doctors at various hospitals. For this study, 210 patients with IBS in the age range of 18 and 64 years are required. The purpose of this study is to find out whether the daily intake of Bimuno, a dietary supplement with galacto-oligosaccharides (hereafter called GOS), can reduce symptom severity of patients with IBS. We compare the effects of Bimuno with the effects of a placebo. IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during defecation or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. The chronic and bothersome nature of IBS symptoms negatively affects the quality of life of many patients. Because there are currently limited medical treatment options for IBS, it is important to study new treatments. IBS can (in part) be caused by an ‘imbalance’ of the bacteria residing in your intestinal tract. The consumption of non-digestible food ingredients, such as GOS, may stimulate the growth of these beneficial bacteria. GOS is a type of ‘prebiotic’, which is known to support health and wellbeing of consumers. By restoring the bacterial balance of the intestinal tract, the symptoms of IBS may be reduced after consumption of GOS. The health effects of GOS have previously been studied in patients with IBS, which demonstrated a reduction in IBS symptom severity and improvements on stool quality and quality of life. In this study, we want to further evaluate how GOS may improve symptoms of IBS. All patients will complete a 2-week run-in period without intervention and will then be matched 1:1 to receive 8 weeks of intervention with either Bimuno or placebo (double-blind).
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0293
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion