An interventional study of washed microbiota transplantation and placebo in Diabetic Gastroparesis, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
At least 44 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, Gastroparesis Cardinal Symptom Index (GCSI), Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM), Gastroparesis Core Symptom Daily Diary (GCS-DD), Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL), and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
This study's planned enrollment of 46 is close to the median of 42 across 215 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following inclusion criteria to enter the study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
Subjects who:
Have any of the following abnormalities in cardiac function and cardiac performance:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient will receive WMT once daily for a duration of 2 days
Other: washed microbiota transplantation
The patient will receive a placebo of equal volume once daily for a duration of 2 days
Other: placebo
Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive two doses of WMT for DGP.
A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.
Response rate of DGP after WMT
The response rate for each study group is defined as the number of responders divided by the total number of participants enrolled in that study group. A responder is defined as a participant who achieves at least a 50% decrease in the total Gastroparesis Cardinal Symptom Index (GCSI) score at Week 4 after WMT. A non-responder is defined as a participant who does not achieve at least a 50% decrease in the total GCSI score at Week 4, or who withdraws from the study early or switches to another treatment for any reason before the Week 4 assessment.
Time frame: Four-week post-WMT
The extent of change observed in GCSI of participants;
The GCSI consists of nine items and three subscales to measure symptoms related to gastroparesis. The nausea/vomiting subscale consists of the following three items: nausea, retching, and vomiting. The postprandial fullness/early satiety subscale consists of the following four items: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite.
Time frame: One-week, Two-week and Eight-week post-WMT
The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants;
GCS-DD consists of 13 items for evaluating the core symptom for past 24 hours.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants;
Questionnaire was developed to measure specific symptoms of patients with upper gastrointestinal disorders. It records 20 symptoms (6 subscales) and assesses their severity within the 2 weeks prior to the test. Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe). The PAGI-SYM subscale scores have good internal consistency and test-retest reliability.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants;
The PAGI-QoL contains 30 items with five subscales: (1) daily activities (1-10); (2) clothing (11-12); (3) diet/food habits (13-19); (4) relationship (20-22); (5) psychological well-being and distress (23-30). Subscale scores are calculated by averaging the item responses.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The extent of change observed in electrogastrogram (EGG) of participants;
The frequency of gastric electric waves will be evaluated by EGG.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The extent of change observed in electrogastrogram (EGG) of participants;
The amplitude of gastric electric waves will be evaluated by EGG.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The extent of change observed in gastrointestinal ultrasound (GIUS) of participants;
The half gastric emptying time will be evaluated by GIUS.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The incidence rate of adverse events;
The number of adverse reactions reported by subjects in the WMT group from the start of treatment to the end of follow-up, divided by the total number of WMT treatments.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
The changes in gut microbiota composition and metabolites before and after treatment.
The 16s-RNA or meta-analysis of gut microbiota will be used.
Time frame: One-week, Two-week, Four-week and Eight-week post-WMT
Plan to share: No
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The Second Hospital of Nanjing Medical University