Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
China40 participantsStarted 2024-04-20
Plain-language summary
The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:
* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
* Glycated hemoglobin (HbA1c) \< 11.0%.
Exclusion Criteria:
* Insulin dependent diabetes;
* Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
* Severe diabetic complications;
* Thyroid disease, malignancies, severe cognitive impairment and mental disease;
* Alcohol or substance abuse;
* Pregnancy or lactation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastrointestinal Symptom Rating Scale
Timeframe: 0 days，weeks 1, 4, and 12 post-treatment
2
Gut Microbiome Sequencing
Timeframe: 0 days，weeks 12 post-treatment
Trial details
NCT IDNCT06340828
SponsorThe Second Hospital of Nanjing Medical University