Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Washing Microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: Diabetic Gastroparesis, Diabetic Gastropathy, Diabetic Gastroenteropathy, Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Washing 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.
Primary outcome measures
- Gastrointestinal Symptom Rating Scale [Time frame: 0 days，weeks 1, 4, and 12 post-treatment]
- Gut Microbiome Sequencing [Time frame: 0 days，weeks 12 post-treatment]
Secondary outcome measures (5)
- Gastroparesis Cardinal Symptom Index [Time frame: 0 days，weeks 1, 4, and 12 post-treatment]
- Composite Autonomic Symptom Score 31 [Time frame: 0 days，weeks 1, 4, and 12 post-treatment]
- Gastrointestinal Motility [Time frame: 0 days，weeks 12 post-treatment]
- Heart Rate Variability [Time frame: 0 days，weeks 12 post-treatment]
- Serum Metabolites [Time frame: 0 days，weeks 12 post-treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06340828 · 2023-KY-186-01