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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT06051318
Eligibility Criteria:
Inclusion Criteria:
* BMI \> 18.5 and \< 30
* Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study
* Own a mobile phone with NFC technology
* Willing to provide a fecal swab sample and a stool sample
* Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP)
Exclusion Criteria:
* Pregnant or lactating women
* Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease)
* Intolerance or allergy to any diet ingredient
* Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease
* Diabetes diagnosis
* Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months
* Use of hypoglycemic medication
* Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months
* Use of laxative medications in the last 30 days
* Underwent invasive procedures or surgery in the last 6 months
* Admission to ICU in the last 2 years
* Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251/97
* Inability to read and understand the informed consent form
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06051318
Study Brief:
Protocol Section:
NCT06051318