The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
⁃ Subjects must meet all of the following inclusion criteria to enter the study:
• Diagnosed with diabetes for over 1 year;
• Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3;
• Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
• Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
• Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
• The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.