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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04364750
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-75 with IBS (Rome IV criteria) who have self-reported previous improvement in their IBS symptoms while on a low FODMAP diet, or when excluding certain high-FODMAP foods, or patients in whom histamine is expected to play a key role (either diagnosed with high histamine producing bacteria, or improved IBS symptoms after using antihistamines). Individuals should be able to swallow size 00 capsules.
Exclusion Criteria:
* Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.)
* Concurrent systemic disease (such as diabetes) and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
* History of active cancer in the last 5 years, other than basal cell cancer
* Pregnant or breastfeeding women
* Active or recent participation (\< 1 month) in a clinical study, except for SPOR IMAGINE
* Use of antibiotics, probiotics, or ACE inhibitors during, or one month prior to the study
* Use of new medications less than 4 weeks prior to the study.
* Allergies to any of the ingredients used in the study
* Any immune-compromising conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04364750
Study Brief:
Protocol Section:
NCT04364750