Irritable Bowel Syndrome
Conditions
Interventions
GOS & Placebo
Sponsors
Clasado Research Services Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with IBS within 36 months prior to study entry 2. Confirmed IBS according to Rome-IV criteria (determined by Investigator) 3. An IBS Symptom Severity Scale score of =125 points at baseline 4. Male or female between 18 and 64 years of age (age ranges included) 5. Possession of a smartphone 6. Willing and eligible to provide consent and comply with protocol and product intake.
Exclusion criteria
Exclusion criteria: 1. Unclassifiable IBS (IBS-U) as determined by Investigator 2. Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry. o Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion. 3. Systemic antibiotic or antimycotic treatment within 4 weeks prior to study entry 4. Use of laxatives or antidiarrheal medication within 4 weeks prior to study entry 5. Use of high-dose antidepressants/antipsychotics (>50mg) within 6 months prior to study entry. Low-dose antidepressants/antipsychotics should be stable for 3 months prior to study entry. 6. 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. 7. 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. 8. Galactosemia (galactose metabolism disorder) 9. 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). 10. Severe illness(es) or medical condition(s), including gastrointestinal pathologies: o ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, auto-immune diseases (e.g. Rheumatoid Arthritis, Systemic lupus erythematosus, Multiple Sclerosis, Graves’ Disease), bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition 11. 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 12. Recent unintended weight loss: o >5% of total body weight within 6 months prior to study entry 13. Excessive alcohol consumption (>10 units per week) and/or drug abuse 14. Pregnancy and lactation, or plan to become pregnant during the study period 15. Participation in other studies involving investigational or marketed products concomitantly or within 3 months prior to study entry 16. Changes in diet, supplement use or medication likely to affect study outcomes within 3 months prior to study entry or planned during the study (at the discretion of the Investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in total IBS symptom severity between treatment arms as measured by mean composite IBS Symptom Severity Scale scores at the end of the study (Day 56). | — |
Secondary
| Measure | Time frame |
|---|---|
| I. The difference in abdominal pain between treatment groups as measured by the mean abdominal pain symptom scores during the intervention period. II. The difference in bloating between treatment groups as measured by the mean bloating symptom scores during the intervention period. III. The difference in global IBS improvement between treatment arms as measured by the mean IBS Global Improvement Scale scores during the intervention period. IV. The difference in stool consistency between treatment arms, per subtype of IBS, as measured by the median Bristol Stool Form Scale stool type during the intervention period. V. The difference in defecation frequency between treatment arms, per subtype of IBS, as measured by the mean patient-reported defecation frequency during the intervention period. VI. The difference in quality of life between treatment arms as measured by the mean composite IBS Quality of Life scores at the end of the study (Day 56). VII. The difference in anxiety and depression between treatment arms, evaluated separately using the mean IBS Hospital Anxiety and Depression Scale scores at the end of the study (Day 56). VIII. Nature, incidence, frequency, severity of adverse events/serious adverse events and relationship to the study intervention. | — |
Contacts
Public ContactLucien Harthoorn
Clasado Research Services Ltd.
Outcome results
None listed