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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT05765292
Eligibility Criteria:
Inclusion Criteria:
* adult participants (aged 18 to 75);
* presence of T2D diagnosis based on the criteria of the American Diabetes Association (plasma glucose in fasting state ≥7.0 mmol/l; plasma glucose at random measuring ≥11.1 mmol/l; HbA1c ≥6.5% or glucose \> 11.1 mmol/l 2 hours after tolerance test with 75 g of glucose);
* presence of pancreatic β-cell dysfunction which defined as HOMA2-β\<50%;
* treatment with insulin therapy alone or in combination with oral anti-diabetic drugs (metformin and/or sulphonylureas) in a stable dose for at least 3 months prior to randomization;
* HbA1c level 6.5 to 11.0%;
* signed informed consent
Exclusion Criteria:
* presence of T1D;
* intake of anti-diabetic drugs except for those specified in the inclusion criteria (pioglitazone, glucagon-like peptide (GLP-1) analogs, dipeptide-peptidase 4 (DPP-4) inhibitors, etc.);
* severe diabetes-related complications at screening (ie, end-stage diabetic kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
* regular intake of probiotics, prebiotics or antibiotics for 3 months prior the inclusion;
* previously diagnosed allergy to probiotics;
* gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis;
* an uncontrolled cardiovascular or respiratory disease, an active malignant tumor or chronic infections;
* participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;
* participation in another clinical trial;
* pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05765292
Study Brief:
Protocol Section:
NCT05765292