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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT04340661
Eligibility Criteria:
Inclusion Criteria:
* willing of sign written informed consent;
* participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
* body weight between 48 and 104 kg, with a BMI less than 27
* age between 18 and 65 years old
Exclusion Criteria:
* participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
* women who suspect to be/are pregnant or in lactacy
* participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
* participants who are intolerant to lactose or with food allergies confirmed
* particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
* participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation
* participants under anticoagulant therapy or with coagulation disease
* participants with renal and hepatic failure
* participants who have taken any investigational drug within 2 month the randomization visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04340661
Study Brief:
Protocol Section:
NCT04340661