Washed Microbiota Transplantation for Diabetic Gastroparesis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe Second Hospital of Nanjing Medical University

About this trial

This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • washed microbiota transplantation
  • placebo

Treatment groups

46 Participants
are divided into 2 treatment groups