Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT05157061
Eligibility 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
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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05157061
Study Brief:
Protocol Section:
NCT05157061