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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT05045768
Eligibility Criteria:
Inclusion Criteria:
Patients with diarrhea-predominant post-infectious IBSand patients with diarrhea predominant classical IBS (non PI-IBS) who will be used as controls
Diagnosis of IBS will be made according to the ROME iV criteria as following:
Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
* Related to defecation
* Associated with a change in frequency of stool
* Associated with a change in form (appearance) of stool. The above-mentioned criteria have to be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
Diagnosis of post infectious IBS will be made according to the Rome Foundation Working Team criteria as following:
Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, with symptom onset at least 6 months before diagnosis, associated with two of the following:
1. defecation
2. a change in frequency of stool
3. a change in form (appearance) of stool Symptom development immediately after resolution of acute infectious gastroenteritis
Infectious gastroenteritis should be defined by positive stool culture in a symptomatic individual or presence of two of the following acute symptoms (when stool culture not available):
1. fever
2. vomiting
3. diarrhea
Exclusion Criteria:
* Patients should not meet criteria for IBS before onset of acute illness.
* We will exclude patients who are pregnant, who have an oncology history (since these patients might exhibit diarrhea due to their underlying illness) and patients with alcohol dependence (due to the non-compliance shown by these patients) and patients with known hypersensitivity or allergy to any of the ingredients included in Gelsectan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05045768
Study Brief:
Protocol Section:
NCT05045768