Actively Recruiting
Washed Microbiota Transplantation for Diabetic Gastroparesis
Led by The Second Hospital of Nanjing Medical University · Updated on 2025-09-10
46
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
CONDITIONS
Official Title
Washed Microbiota Transplantation for Diabetic Gastroparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with diabetes for over 1 year
- Experiencing symptoms such as abdominal bloating or early satiety for at least 3 months, with a Gastroparesis Cardinal Symptom Index Total Score of 2.3 or higher
- Objective evidence of delayed gastric emptying within the past 3 months confirmed by tests like scintigraphic gastric emptying or gastric ultrasound
- No upper gastrointestinal obstructive lesions based on imaging or endoscopic examination within the past 3 months
- Male or nonpregnant, non-breastfeeding female aged over 18 years
- Able to give informed consent, understand the study purpose, communicate effectively, and comply with study requirements
You will not qualify if you...
- Presence of upper gastrointestinal diseases other than diabetic gastroparesis requiring different treatments
- History of gastric surgery such as gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy within the past year
- Organic or neurological diseases causing gastroparesis other than diabetes
- Use of medications affecting gastrointestinal motility, including GLP-1 agonists
- Contraindications for intestinal tubing
- Use of medications regulating intestinal microbiome within the last 48 hours
- Serious diabetic complications needing immediate treatment, like diabetic ketoacidosis
- Poor lung function or conditions like COPD exacerbations affecting study treatment
- Significant cardiac issues including NYHA class III or above, recent heart attack or unstable angina, prolonged QTc interval, or advanced atrioventricular block
- Preexisting liver disease classified as Child-Pugh Class B or C
- Kidney disease with KDIGO stage 3b or worse (GFR <45 ml/min/1.73m2)
- Active infectious diseases such as hepatitis requiring long-term drugs, HIV, or active tuberculosis
- History of drug abuse, alcoholism (more than 14 units per week), or substance misuse
- Other serious systemic illnesses like malignant tumors
- Any other condition deemed inappropriate for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
F
Faming Zhang, PhD
CONTACT
B
Bota Cui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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