IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements 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 the intestinal tract. For instance, there may be a lower proportion of specific bacteria that are generally considered beneficial for a persons health. 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 the study product (a specific GOS) used in current study was previously investigated in a small group of patients with IBS. Use of the study product indicated a reduction in the patients' symptoms, improvement in the patients' quality of life, and changes in patients' gut bacteria. It is therefore hypothesized that GOS / a specific GOS may reduce the symptom severity of patients with IBS. This study further evaluates how GOS may improve symptoms of IBS.
A Phase III, randomized, double-blind, placebo-controlled, multi-centre, 8-week intervention study, preceded by a 2-week run-in period, to assess the efficacy of GOS on symptom severity in adult patients with IBS. The study population will consist of 210 adult patients diagnosed in the past 36 months with IBS-Diarrhoea (N =70), IBS-Constipation (N = 70), or IBS-Mixed (N =70). Irritable bowel syndrome (IBS) is a highly prevalent and multifaceted functional bowel disorder characterized by recurrent abdominal pain associated with defecation or a change in bowel habits in the absence of detectable structural and biochemical abnormalities. Disordered bowel habits are typically present, such as constipation, diarrhoea or a mix of constipation and diarrhoea, as are symptoms of abdominal bloating/distension. The chronic and bothersome nature of IBS symptoms negatively affects patients' quality of life and introduces a substantial economic burden on patients and the healthcare system. The gut microbiota composition and function may play a pivotal role in the pathogenesis of IBS, as a reduction in endogenous bifidobacteria, lactobacilli, and Faecalibacterium prausnitzii concentrations, as well as small bowel bacterial overgrowth have been reported in IBS patients, thereby introducing the gut microbiota as a potential target for treatment and symptom relief. Intervention with non-digestible food ingredients, such as galacto-oligosaccharides (GOS), may form a suitable intervention strategy, as these 'prebiotics' are known to modulate the gastrointestinal (GI) microbiota and support health and wellbeing of the host. The safety and efficacy of GOS has previously been evaluated in patients with IBS, which demonstrated that GOS may reduce IBS symptom severity, improve quality of life, improve stool consistency and defecation frequency and alter gut microbiota composition, in a safe manner. As there are currently limited suitable medical treatments for IBS, this study will evaluate the efficacy of GOS in reducing symptom severity of patients with IBS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a prebiotic supplement is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.
An 8-week intervention study, preceded by a 2-week run-in period, in which a daily dose of a placebo is given to adult patients diagnosed with IBS (diarrhoea, constipation or mixed-type). Patients need to report several symptom experiences and blood and faecal samples are collected.
University Hospital Leuven location Gasthuisberg
Leuven, Belgium
Jeroen Bosch Ziekenhuis, Gastroenterology department
's-Hertogenbosch, North Brabant, Netherlands
Medisch Centrum Leeuwarden (MCL)
Leeuwarden, Provincie Friesland, Netherlands
Ziekenhuis Gelderse Vallei, Afdeling Maag-Darm-Leverziekten
Ede, Netherlands
Leeds Teaching Hospital NHS Trust in association with the University of Leeds
Leeds, North Yorkshire, United Kingdom
County Durham &Darlington NHS Foundation trust, University Hospital of North Durham
Durham, United Kingdom
Barts Health NHS Trust, Wingate Clinical Trials Facility
London, United Kingdom
Manchester University NHS Foundation Trust, Wythenshawe Hospital, Neurogastroenterology Unit
Manchester, United Kingdom
NIHR National Patient Recruitment Centre Newcastle
Newcastle upon Tyne, United Kingdom
IBS symptom Severity
The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores. The IBS System Severity Scores Scale consists of 5 questions each with scales ranging from 0 to 100, divided into steps of 10, whereby a score of 0 reflects the best outcome, and a score of 100 reflects the worst outcome.
Time frame: Baseline to end of the study (Day 56).
Abdominal pain
The difference in abdominal pain between treatment groups as measured by the mean abdominal pain symptom scores as reported by patients in their electronic diaries. Patients are requested to rate their worst abdominal pain over the past 24 hours on a scale from 0 = no abdominal pain, 10 = worst possible abdominal pain.
Time frame: During the intervention period (8 weeks)
Bloating.
The difference in bloating between treatment groups as measured by the mean bloating symptom scores as reported by patients in their electronic diaries. Patients are requested to to rate their worst bloating symptoms over the past 24 hours, on a scale from 0 = no bloating, 10 = worst possible bloating.
Time frame: During the intervention period (8 weeks)
Global IBS improvement
The difference in global IBS improvement between treatment arms as measured by the mean IBS Global Improvement Scale scores. Patients are requested to rate their IBS signs or symptoms overall over the past 7 days on a scale from 1 = significantly relieved to 7 = significantly worse.
Time frame: During the intervention period (8 weeks)
Stool consistency
The difference in stool consistency between treatment arms, per subtype of IBS\*\*, as measured by the median Bristol Stool Form Scale stool type. The Bristol Stool Form Scale stool types vary from 1 (separate hard lumps) to 7 (watery, no hard pieces). Normal stools would be rated in the middle of this scale (3, 4, or 5)
Time frame: During the intervention period (8 weeks)
Defecation frequency
The difference in defecation frequency between treatment arms, per subtype of IBS\*\*, as measured by the mean patient-reported defecation frequency.
Time frame: During the intervention period (8 weeks)
Quality of Life IBS-QOL score
The difference in quality of life between treatment arms as measured by the mean composite IBS Quality of Life scores. The IBS Quality of Life validated questionnaire offers patients 34 statements concerning bowel problems (Irritable Bowel Syndrome, IBS) and how these affected the patient over the past 30 days, Scores range from 1 (not at all) to 5 (extremely)
Time frame: At the end of the study (Day 56)
Anxiety and depression
The difference in anxiety and depression between treatment arms, evaluated separately using the mean IBS Hospital Anxiety and Depression Scale scores. The Hospital Anxiety and Depression scale asks patients to rate how they feel in 14 questions, each offering 4 different outcomes ranging from the best possible feeling to worst possible feeling
Time frame: At the end of the study (Day 56)
Nature, incidence, frequency, severity of adverse events/serious adverse events and relationship to the study intervention.
To assess the safety of treatment with GOS in patients with IBS
Time frame: During the intervention period (8 weeks)
Rescue medication
Difference in use of rescue medication between treatment arms
Time frame: From screening to end of intervention period (10 weeks)
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