GOS to Reduce Symptom Severity in IBS

Who can take part

• 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

Who cannot take part

• Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g. Yakult, Actimel, Activia, VSL#3, Kefir); o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion
• 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)
• Subjects suffering from auto-immune disorders (e.g. Rheumatoid Arthritis, Systemic lupus erythematosus, Multiple Sclerosis, Graves' Disease) that require treatment with an immune modulator treatment or anti-inflammatory medication
• Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior to study entry, or planned during the study; o Appendectomy within 6 months prior to study entry
• Recent unintended weight loss:; o >5% of total body weight within 6 months prior to study entry
• Excessive alcohol consumption (>14 units per week) and/or drug abuse
• Participation in other studies involving investigational or marketed products concomitantly or within 3 months prior to study entry
• Changes in diet, supplement or medication use likely to affect study outcomes (i.e. medication that influences GI function) within 4 weeks prior to study entry or planned during the study (at the discretion of the Investigator). For example, the following medications will influence GI function and changes must be avoided: opioids, prokinetics (domperidone, metoclopramide, prucalopride), antispasmodics (peppermint oil, buscopan), and acid suppressants (PPI, H2 blockers). Of note: the intake of fibres (e.g. psyllium husk) may be used provided that the participant has been using this as a supplement for more than 4 weeks prior to study participation and intake does not change during the course of participation
• 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
• Galactosemia (galactose metabolism disorder)
• Severe illness(es) or medical condition(s), including gastrointestinal pathologies:; o GI ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, , bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition
• Unclassifiable IBS (IBS-U) as determined by Investigator
• 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
• Following diets likely to affect study outcomes, including:; o low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets (GOS is derived from cow's milk)
• Pregnancy and lactation, or plan to become pregnant during the study period