Subject recruitment
cerebral apoplexy, mental illness, cancer, coronary heart disease, organic diseases, hepatic diseases, T2DM
HEPATIC DISEASE, TYPE 1 DIABETES, ORGANIC DISEASE
This study was a randomized, open-label, parallel-group clinical trial in T2DM patients with a 4-week treatment period. The study was performed according to the principles of the Declaration of Helsinki (2008), and the study protocol was approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine (ID: SNPH2017-026). All the participants signed the informed consent forms.During the initial screening period, patients with plasma HbA1c levels (6.5%-12.0%) were recruited. Patients who had taken antibiotics, probiotics and prebiotics during the previous 3 months were excluded. Other exclusive criteria included type 1 diabetes, severe hepatic diseases, gastrointestinal surgery and severe mental illness. Patients were also excluded if they had severe organic diseases, including cancer, coronary heart disease, and cerebral apoplexy.