NCT06340828Not yet recruitingNot Applicable
Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
The Second Hospital of Nanjing Medical University1 site in 1 country40 target enrollmentStarted: April 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Gut Microbiome Sequencing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Gut Microbiome Sequencing
Time Frame: 0 days，weeks 12 post-treatment
16S rRNA Sequencing
Gastrointestinal Symptom Rating Scale
Time Frame: 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 Outcomes
- Serum Metabolites(0 days，weeks 12 post-treatment)
- Gastrointestinal Motility(0 days，weeks 12 post-treatment)
- Gastroparesis Cardinal Symptom Index(0 days，weeks 1, 4, and 12 post-treatment)
- Composite Autonomic Symptom Score 31(0 days，weeks 1, 4, and 12 post-treatment)
- Heart Rate Variability(0 days，weeks 12 post-treatment)
Investigators
Study Sites (1)
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