Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Mar 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called washed microbiota transplantation to see if it can help people with digestive problems caused by diabetes, specifically conditions like diabetic gastroparesis and diabetic gastroenteropathy. The researchers want to find out how effective and safe this treatment is, as well as what factors might affect how well it works. They will also study the gut bacteria in patients with these disorders to better understand their condition.

To participate in this trial, you need to have type 2 diabetes and a diagnosed gastrointestinal motility disorder, and your blood sugar levels should be within a certain range. Unfortunately, if you rely on insulin, have severe digestive diseases, or certain other health issues, you won't be eligible for this study. Participants will need to provide some blood and stool samples before starting the treatment and again after 12 weeks, as well as complete assessments at various times during the trial. The study is not yet recruiting, but it aims to help improve treatment options for people facing these challenging digestive issues related to diabetes.

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Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
• • Glycated hemoglobin (HbA1c) \< 11.0%.
• Exclusion Criteria:
• • Insulin dependent diabetes;
• • Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
• • Severe diabetic complications;
• • Thyroid disease, malignancies, severe cognitive impairment and mental disease;
• • Alcohol or substance abuse;
• • Pregnancy or lactation.