Diabetic Gastroenteropathy, Diabetic Gastroparesis, Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus, Diabetic Gastropathy
Conditions
Brief summary
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.
Interventions
OTHERWashing Microbiota Transplantation
Fecal 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.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | 0 days，weeks 1, 4, and 12 post-treatment | Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome. |
| Gut Microbiome Sequencing | 0 days，weeks 12 post-treatment | 16S rRNA Sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastroparesis Cardinal Symptom Index | 0 days，weeks 1, 4, and 12 post-treatment | Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome. |
| Serum Metabolites | 0 days，weeks 12 post-treatment | Liquid chromatography-mass spectrometry (LC-MS) |
| Gastrointestinal Motility | 0 days，weeks 12 post-treatment | Neurophysiological Method |
| Composite Autonomic Symptom Score 31 | 0 days，weeks 1, 4, and 12 post-treatment | Questionnaires，the minimum score is 0，and maximum is 75, and higher scores mean a worse outcome. |
| Heart Rate Variability | 0 days，weeks 12 post-treatment | Neurophysiological Method |
Countries
China
Contacts
Primary ContactSijing Wang, Master's student
Backup ContactDafa Ding, Professor
Outcome results
None listed