Washed Microbiota Transplantation for Diabetic Gastroparesis

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called washed microbiota transplantation (WMT) for patients suffering from diabetic gastroparesis, a condition where the stomach takes too long to empty its contents. The trial aims to see if WMT can help improve symptoms like bloating and feeling full quickly, which can significantly affect daily life. Researchers are currently recruiting participants who are diagnosed with diabetes for more than a year and have experienced these symptoms for at least three months, along with specific tests showing delayed gastric emptying.

To join the study, participants must be over 18 years old and agree to take part after understanding the study's purpose. However, certain individuals won't be able to participate, such as those with other serious stomach issues, recent stomach surgeries, or certain health conditions affecting the heart or lungs. If you are eligible and choose to participate, you will be closely monitored throughout the trial to ensure your safety and gather important information about the treatment's effectiveness. This study offers a potential new approach to managing diabetic gastroparesis and could lead to more effective treatments in the future.

Gender

ALL

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.