Diabetic GastroparesisNCT06340828
Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
A study testing Washing Microbiota Transplantation in people with Diabetic Gastroparesis and Diabetic Gastropathy, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Gastroparesis, Diabetic Gastropathy, Diabetic Gastroenteropathy
- What is being tested?
- Washing Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 20 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
- Glycated hemoglobin (HbA1c) < 11.0%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Dafa Ding, Professor, +8615850514014, dingdafa@njmu.edu.cn
About this study
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.
- Conditions
- Diabetic Gastroparesis, Diabetic Gastropathy, Diabetic Gastroenteropathy, Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus
- Being tested
- Washing Microbiota Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washing Microbiota TransplantationOther
Also called Fecal Microbiota Transplantation
Fecal samples from healthy adults were collected and underwent multiple centrifugations and filtrations to obtain a bacterial solution, which was then transplanted into the duodenum of patients via a nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Washing Microbiota Transplantation (WMT) group | Experimental | After assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment. Receives: Other: Washing Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale
Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.
Measured: 0 days，weeks 1, 4, and 12 post-treatment
Gut Microbiome Sequencing
16S rRNA Sequencing
Measured: 0 days，weeks 12 post-treatment
Secondary outcomes (5)
Gastroparesis Cardinal Symptom Index
Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.
Measured: 0 days，weeks 1, 4, and 12 post-treatment
Composite Autonomic Symptom Score 31
Questionnaires，the minimum score is 0，and maximum is 75, and higher scores mean a worse outcome.
Measured: 0 days，weeks 1, 4, and 12 post-treatment
Gastrointestinal Motility
Neurophysiological Method
Measured: 0 days，weeks 12 post-treatment
Heart Rate Variability
Neurophysiological Method
Measured: 0 days，weeks 12 post-treatment
Serum Metabolites
Liquid chromatography-mass spectrometry (LC-MS)
Measured: 0 days，weeks 12 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340828
- Sponsor's protocol ID
- 2023-KY-186-01
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT06340828
- Acronym / sponsor ID
- 2023-KY-186-01
- Conditions
- Diabetic Gastroparesis, Diabetic Gastropathy, Diabetic Gastroenteropathy, Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Washing Microbiota Transplantation (WMT) group | Experimental | Other: Washing Microbiota TransplantationAfter assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
- Glycated hemoglobin (HbA1c) < 11.0%.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Washing Microbiota TransplantationAlso: Fecal Microbiota TransplantationFecal samples from healthy adults were collected and underwent multiple centrifugations and filtrations to obtain a bacterial solution, which was then transplanted into the duodenum of patients via a nasogastric tube. | Other | Washing Microbiota Transplantation (WMT) group |
Primary outcome
Gastrointestinal Symptom Rating Scale
Time frame: 0 days，weeks 1, 4, and 12 post-treatment
Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.
Gut Microbiome Sequencing
Time frame: 0 days，weeks 12 post-treatment
16S rRNA Sequencing
5 secondary outcomes
Gastroparesis Cardinal Symptom Index
Time frame: 0 days，weeks 1, 4, and 12 post-treatment
Composite Autonomic Symptom Score 31
Time frame: 0 days，weeks 1, 4, and 12 post-treatment
Gastrointestinal Motility
Time frame: 0 days，weeks 12 post-treatment
Heart Rate Variability
Time frame: 0 days，weeks 12 post-treatment
Serum Metabolites
Time frame: 0 days，weeks 12 post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Washing Microbiota Transplantation in people with Diabetic Gastroparesis and Diabetic Gastropathy, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sijing Wang, Master's student (+8615664579913, 15664579913@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale (time frame: 0 days，weeks 1, 4, and 12 post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.