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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT06283732
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Aged 18-65 years.
* Willing to comply with study requirements.
* No known allergies to the ingredients listed in the product.
* Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
* Generally healthy - do not live with any uncontrolled chronic disease .
Exclusion Criteria:
* Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
* Known severe allergic reactions that require an Epi-Pen.
* Women who are pregnant, breastfeeding, or attempting to conceive.
* History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
* Unwillingness to follow the study protocol.
* Invasive medical procedure within the last three weeks or planning one during the study period.
* History of substance abuse.
* Current participation or planning to participate in another research study.
* Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.
* Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06283732
Study Brief:
Protocol Section:
NCT06283732