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:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06808867
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent to participate in the study.
* Willingness to actively participate in the study and to come to the scheduled visits.
* Female and/or male
* From 18 to 85 years of age
* Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks
Exclusion Criteria:
* Drug addicts, alcoholics.
* AIDS, HIV-positive or infectious hepatitis
* Diabetes mellitus
* Disorders known to affect GI motility such as gastroparesis or amyloidosis.
* Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease
* History of surgery known to alter the normal function of the GI tract.
* Conditions which exclude participation or might influence the test reaction/evaluation.
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
* Documented allergies to cosmetic products and/or ingredients
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.
* Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study
* Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study
* Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.
* One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06808867
Study Brief:
Protocol Section:
NCT06808867