Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-100
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Type 1 Diabetes Mellitus (T1DM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At the time of informed consent, male or non-pregnant or non-lactating female.
The diagnostic criteria for T1DM are confirmed by previous medical record.
The subject or his/her legal representative gives informed consent, fully nderstands 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.
Disqualifiers
Diagnosed as any type of diabetes other than type 1 diabetes mellitus;
Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);
At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
Trial population
National patients with T1DM receiving WMT will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
WMT
Other interventionWashed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT for T1DM.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The mean daily insulin dosage of participants
The mean daily insulin dosage of participants in past week
Time frame
One-week, Two-week, Four-week post-WMTSecondary outcomes
1
The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.
The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol/L) over a 24-hour period
Time frame
One-week, Two-week, Four-week post-WMT2
The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.
The standard deviation of measured values during immediate blood glucose monitoring
Time frame
One-week, Two-week, Four-week post-WMT3
The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.
The range of blood glucose values observed during immediate blood glucose monitoring
Time frame
One-week, Two-week, Four-week post-WMT4
The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.
After filtering out blood glucose fluctuations below a certain threshold (usually 1 SD), the average fluctuation amplitude is calculated based on the direction of the first significant fluctuation
Time frame
One-week, Two-week, Four-week post-WMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov