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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03423069
Eligibility Criteria:
Inclusion Criteria:
* Rome IV criteria for IBS diarrhea variant (IBS-D).
* Low-lactose diet is allowed, provided that patients agree to keep this intake constant throughout the study period, except in the case of randomization in the treatment arm with a low-FODMAPs diet.
* The use of probiotic products is permitted, and patients who consume probiotic products must be instructed to continue taking the same amount previously taken throughout the study period.
* The drugs used to treat IBS, including antidepressants, will be admitted provided they are used regularly and have a stable dosage for at least one month prior to inclusion in the study.
* Patients must be willing to change their current diet to participate in the study for the whole study period.
Exclusion Criteria:
* Serious cardiac, hepatic, neurological or psychiatric diseases.
* GI diseases other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain current symptoms.
* Patients who previously had a low-content diet of particular substances (for example, low FODMAPs content, vegan diet, gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until thes symptoms reappear.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03423069
Study Brief:
Protocol Section:
NCT03423069