This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
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;
Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy in past 1 year;
Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
Parallel
washed microbiota transplantation
Other interventionWashed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive two doses of WMT for DGP.
placebo
Other interventionA carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.
Response rate of DGP after WMT
The response rate for each study group is defined as the number of responders divided by the total number of participants enrolled in that study group. A responder is defined as a participant who achieves at least a 50% decrease in the total Gastroparesis Cardinal Symptom Index (GCSI) score at Week 4 after WMT. A non-responder is defined as a participant who does not achieve at least a 50% decrease in the total GCSI score at Week 4, or who withdraws from the study early or switches to another treatment for any reason before the Week 4 assessment.
The extent of change observed in GCSI of participants;
The GCSI consists of nine items and three subscales to measure symptoms related to gastroparesis. The nausea/vomiting subscale consists of the following three items: nausea, retching, and vomiting. The postprandial fullness/early satiety subscale consists of the following four items: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite.
The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants;
GCS-DD consists of 13 items for evaluating the core symptom for past 24 hours.
The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants;
Questionnaire was developed to measure specific symptoms of patients with upper gastrointestinal disorders. It records 20 symptoms (6 subscales) and assesses their severity within the 2 weeks prior to the test. Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe). The PAGI-SYM subscale scores have good internal consistency and test-retest reliability.
The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants;
The PAGI-QoL contains 30 items with five subscales: (1) daily activities (1-10); (2) clothing (11-12); (3) diet/food habits (13-19); (4) relationship (20-22); (5) psychological well-being and distress (23-30). Subscale scores are calculated by averaging the item responses.
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