About this trial
The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:
* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests. * The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria. * The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes. * The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
Glycated hemoglobin (HbA1c) < 11.0%.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Washing Microbiota Transplantation
Other interventionFecal samples from healthy adults were collected and underwent multiple centrifugations and filtrations to obtain a bacterial solution, which was then transplanted into the duodenum of patients via a nasogastric tube.
Treatment groups
Trial outcomes
Primary outcomes
Gastrointestinal Symptom Rating Scale
Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome.
Gut Microbiome Sequencing
16S rRNA Sequencing
Secondary outcomes
Gastroparesis Cardinal Symptom Index
Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome.
Composite Autonomic Symptom Score 31
Questionnaires,the minimum score is 0,and maximum is 75, and higher scores mean a worse outcome.
Gastrointestinal Motility
Neurophysiological Method
Heart Rate Variability
Neurophysiological Method
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: