Transplanting washed microbiota to treat diabetic gastroparesis

The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

This study is testing whether transplanting cleaned gut bacteria can help people with diabetic gastroparesis feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06340217 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of washed microbiota transplantation (WMT) in patients suffering from diabetic gastroparesis. A total of at least 44 participants will be enrolled, all of whom must meet specific inclusion criteria related to their diabetes and gastrointestinal symptoms. The study will collect various data points, including symptom severity and quality of life assessments, to evaluate the outcomes of the treatment. Participants will also undergo a follow-up period to monitor the effects of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with diabetes for over a year, experiencing specific gastrointestinal symptoms and delayed gastric emptying.

Not a fit: Patients with upper gastrointestinal obstructive lesions or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve gastrointestinal symptoms and quality of life for patients with diabetic gastroparesis.

How similar studies have performed: While the approach of washed microbiota transplantation is relatively novel, similar studies in microbiota medicine have shown promising results in other gastrointestinal conditions.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

1. Diagnosed with diabetes for over 1 year;
2. Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3;
3. Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
4. Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
5. Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
6. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

Subjects who:

1. Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
2. Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy in past 1 year;
3. Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
4. Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
5. Have contraindications for intestinal tubing;
6. Have a history of medication that regulate intestinal microbiome in last 48 hours;
7. Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis
8. Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations;
9. Have any of the following abnormalities in cardiac function and cardiac performance:

   * Cardiac function rating≥Ⅲ according to New York Heart Association (NYHA);
   * New myocardial infarction or unstable angina pectoris within 6 months;
   * Electrocardiogram indicated prolonged QTc interval (male QTc≥450ms, female QTc≥470ms);
   * requiring drug intervention (more than Ⅱ atrioventricular block).
10. Have preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points);
11. Kidney disease with KDIGO stage 3b (GFR\<45 ml/min/1.73m2) or above;
12. Have infectious diseases such as active hepatitis (requiring long-term use of drugs), HIV or active tuberculosis;
13. Have a history of drug abuse, alcoholism (defined as consuming more than 14 units per week, with 1 unit equivalent to 360 mL of beer, 45 mL of 40% alcohol, or 150 mL of wine), or substance misuse;
14. Other significant systemic illnesses, such as malignant tumors;
15. Have other situations in which the investigator deems it inappropriate to participate in this study.

Where this trial is running

Nanjing, Jiangsu

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Faming Zhang — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD

Conditions Diabetic Gastroparesis; washed microbiota transplantation; diabetic gastroparesis; randomized controlled trial; transendoscopic enteral tube; microbiota medicine