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New treatment option for Diabetic Gastroparesis
Official title Washed Microbiota Transplantation for Diabetic Gastroparesis
ClinicalTrials.gov ID: NCT06340217
What this study is testing
- What it's testing
- This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- people must meet all of the following to enter the study:
- Diagnosed with diabetes for over 1 year;
- Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to...
- Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric...
- Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
You likely can't join if
- people meeting any of the following exclusion criteria must be excluded from the study: people who:
- Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
- Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or...
- Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
- Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
- Have contraindications for intestinal tubing;
See the full eligibility criteria
- people must meet all of the following to enter the study:
- Diagnosed with diabetes for over 1 year;
- 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;
- Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
- Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
- Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
- 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...
- people meeting any of the following exclusion criteria must be excluded from the study: people who:
- Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
- 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;
- Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
- Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
- Have contraindications for intestinal tubing;
- Have a history of medication that regulate intestinal microbiome in last 48 hours;
- Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis
- Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations;
- 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).
- 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);
- Kidney disease with KDIGO stage 3b (GFR\<45 ml/min/1.73m2) or above;
- Have infectious diseases such as active hepatitis (requiring long-term use of drugs), HIV or active tuberculosis;
- 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;
- Other significant systemic illnesses, such as malignant tumors;
- Have other situations in which the investigator deems it inappropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.