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:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT04974593
Eligibility Criteria:
Inclusion Criteria:
* Fulfilling the ROME IV criteria for IBS;
* Moderate symptom severity as defined by a IBS-SSS \> 175;
* Consumption of lactose containing products.
Exclusion Criteria:
* Clinical suspicion of an organic disorder different from LI or IBS (patients can be included when this disorder had been excluded);
* Known lactose intolerance or malabsorption;
* Known inflammatory bowel disorder;
* Known intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of appendectomy);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 8 weeks;
* Intake of antibiotics, pre- or probiotics during the past 8 weeks;
* Dietary supplements unless taken at a stable dose for more than 8 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
* Treatment with spasmolytic agents, opioids, loperamide, gelatin tannate or mucoprotect-ants during the past 8 weeks;
* LFD or low FODMAP diet in the past
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04974593
Study Brief:
Protocol Section:
NCT04974593