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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT07121803
Eligibility Criteria:
Inclusion Criteria:
* willingness to participate based on signed written informed consent;
* controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:
* no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
* doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or insulin.
* no new medications during participation in the study
Exclusion Criteria:
* Pregnancy and breastfeeding;
* Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM \> or = 14 kPa by Fibroscan), or APRI \> or= 1; or BARD score \> or = 2.
* Diarrhea of any type (watery stool more than 3 times a day).
* Chronic heart failure (I-IV class by NYHA).
* Past major abdominal or chest surgery, including bariatric procedures and fundoplication (except appendectomy or cholecystectomy performed more than a year before enrollment).
* Achalasia and esophago-gastric junction outflow obstruction
* Major esophageal motility disorders according to Chicago IV classification.
* Clinically relevant acute cardiovascular event within 6 months prior to screening.
* Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.
* Diabetes mellitus type 1.
* The level of glycated hemoglobin \[HbA1c\] \>9.0%.
* Hypersensitivity to the studied product or any of its components, including lactose intolerance.
* The intake of any pharmaceutical agents with known influence on esophageal motility (including, but not limited to: beta-blockers, calcium channel blockers, m-cholinoblockers, myorelaxants, antidepressants, tranquilizers, prokinetic agents)
* Any medical conditions that may significantly affect life expectancy, including known cancers;
* Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases;
* Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol;
* Inability to tolerate high-resolution esophageal manometry without sedation, at least in part.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07121803
Study Brief:
Protocol Section:
NCT07121803