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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT05680766
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 - 60 years;
* Fulfilling the ROME IV criteria for Irritable bowel syndrome (IBS);
* Moderate symptom severity as defined by a IBS-Symptom Severity Scale \> 175;
* Sedentary lifestyle defined as SIT-Q-7D \> 8h/day;
* Physically inactive defined as \< 150min/week on the IPAQ score
Exclusion Criteria:
* Cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (SKA) questionnaire.
* Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
* 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 or cholecystectomy more than 6 months ago);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 8 weeks;
* Change in diet in the past 8 weeks;
* Dietary supplements unless taken at a stable dose for more than 8 weeks;
* Antibiotics, pre-, pro-, post-biotics or any combination during the past 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, gelatine tannate or mucoprotect-ants during the past 8 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05680766
Study Brief:
Protocol Section:
NCT05680766