Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus

Exclusion Criteria

• •Crohn's disease, liver cirrhosis, human immunodeficiency virus (HIV) or any other active systemic bacterial, viral or fungal infections
• •BMI \> 42
• •Severe hypoglycemias within 3 months prior to the start date of the study
• •Abnormal glycated hemoglobin measurements (over 8%) prior to the start date of the study
• •Prescription of a new antidiabetic medication in the last 6 months
• •Celiac disease or any other food intolerances
• •Use of antibiotics, probiotics and/or prebiotics within 2 weeks prior to the start date of the study
• •Chronic liver disease with a C Child-Plug score, chronic kidney disease with creatinine clearance \< 50 ml/min as well as any other clinically significant conditions including pulmonary, neurological and cardiovascular diseases according to the investigators medical opinion
• •Patients with history or presence of malignancy who have been treated with systemic antineoplastic therapy within 6 months prior to the start date of the study
• •Pregnancy and breastfeeding
• •Not being able to provide written informed consent to participate in the study or to cooperate and comply with the study procedures for any other reason