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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02469558
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Age above 18 years
* Type 2 diabetes
* BMI 30-40 kg/m²
* HbA1c ≥ 6.5% (48 mmol/mol)
* Stable diabetes therapy over 6 months
* Person commits to the need for long-term follow-up
Exclusion Criteria:
* Type 1 diabetes mellitus
* Maturity Onset Diabetes of the Young (MODY)
* Secondary diabetes due to a specific disease or glucocorticoid therapy
* Pregnancy
* Hypothalamic cause of obesity, Cushing syndrome
* Major psychiatric diseases including diagnosed eating disorders, history of drug or alcohol abuse
* History of bariatric surgery
* Use of probiotics (other than the study product)
* Antibiotic therapy within the last 4 weeks before inclusion
* Inflammatory bowel disease
* Pancreatitis
* Chronic non-steroidal anti-inflammatory drug (NSAID) treatment
* glucagon-like peptide-1 receptor agonist therapy or acarbose therapy
* Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure
* Recent (less than 12 weeks) stroke
* Known malignancy or any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02469558
Study Brief:
Protocol Section:
NCT02469558