Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
- Conditions
- Diabetic GastroenteropathyDiabetic GastropathyDiabetic GastroparesisDiabetic Gastroparesis Associated With Type 2 Diabetes Mellitus
- Interventions
- Other: Washing Microbiota Transplantation
- Registration Number
- NCT06340828
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
- Glycated hemoglobin (HbA1c) < 11.0%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Washing Microbiota Transplantation (WMT) group Washing Microbiota Transplantation After assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment.
- Primary Outcome Measures
Name Time Method Gut Microbiome Sequencing 0 days，weeks 12 post-treatment 16S rRNA Sequencing
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.
- Secondary Outcome Measures
Name Time Method Serum Metabolites 0 days，weeks 12 post-treatment Liquid chromatography-mass spectrometry (LC-MS)
Gastrointestinal Motility 0 days，weeks 12 post-treatment Neurophysiological Method
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.
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
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China