GOS to Reduce Symptom Severity in IBS (NCT05157061) | Clinical Trial Compass
CompletedNot Applicable
GOS to Reduce Symptom Severity in IBS
Belgium, Netherlands, United Kingdom153 participantsStarted 2021-10-26
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Patients who have been diagnosed with IBS by a medically trained person/Health Care Professional (HCP).
✓. IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary or secondary care clinician, including a gastroenterologist, at study entry
✓. An IBS Symptom Severity Scale score of ≥125 points at baseline
✓. Male or female between 18 and 64 years of age (age ranges included)
✓. Possession of a smartphone
✓. Willing and eligible to provide consent and comply with protocol and product intake.
Exclusion criteria
✕. Unclassifiable IBS (IBS-U) as determined by Investigator
✕. Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir).
✕. Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry
✕. Use of laxatives or antidiarrheal medication within 1 week prior to study entry
✕. An unstable antidepressant/antipsychotic treatment regimen within 3 months prior to study entry (i.e. treatment should be stable for at least 3 months prior to study entry).
✕. Confirmed lactose intolerance, defined as patients who report response to dietary elimination of lactose/dairy products. Confirmation is patient-reported and not done within the scope of this study.
✕. Confirmed food allergy, with reported confirmation based on OFC, IgE, or skin prick test. Confirmation is patient-reported and not done within the scope of this study.