Irritable Bowel Irritable Bowel Syndrome
Conditions
Interventions
All patients in this study 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):
-
Sponsors
Clasado Research Services Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have been diagnosed with IBS by a medically trained person/Health Care Professional (HCP). 2. IBS diagnosis to be confirmed according to the Rome-IV criteria by a primary or secondary care clinician, including a gastroenterologist, at study entry 3. An IBS Symptom Severity Scale score of >=125 points at baseline (V1) 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 (e.g. Yakult, Actimel, Activia, VSL#3, Kefir). 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 1 week prior to study entry 5. 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). 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 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. 11. 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 12. 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 13. Recent unintended weight loss: o >5% of total body weight within 6 months prior to study entry 14. Excessive alcohol consumption (>14 units per week) and/or drug abuse 15. Pregnancy and lactation, or plan to become pregnant during the study period 16. Participation in other studies involving investigational or marketed products concomitantly or within 3 months prior to study entry 17. 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.
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. IX. Compare the need and usage of rescue medication (anti-diarrheal medication or laxatives) between the 2 treatment arms during the treatment period. | — |
Countries
Netherlands
Outcome results
None listed