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).
At least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.
Study Type
OBSERVATIONAL
Enrollment
50
Washed 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.
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe 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-WMT
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-WMT
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-WMT
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-WMT
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-WMT
The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.
The average absolute difference between corresponding measured values over a continuous 48-hour period
Time frame: One-week, Two-week, Four-week post-WMT
The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.
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The average absolute difference between post-meal blood glucose taken 2 hours after three meals and the corresponding pre-meal blood glucose.
Time frame: One-week, Two-week, Four-week post-WMT
The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.
Average values obtained from immediate blood glucose monitoring
Time frame: One-week, Two-week, Four-week post-WMT
The coefficient of variation (CV, percent) of type 1 diabetes mellitus.
CV=(SDBG÷MBG)×100%
Time frame: One-week, Two-week, Four-week post-WMT
The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week
Hypoglycemia is defined as blood glucose \< 3.9 mmol/L
Time frame: One-week, Two-week, Four-week post-WMT
The islet β-cell function after WMT compared with baseline
2-hour postprandial C-peptide release was used to reflect islet β-cell function
Time frame: Three-day, One-week, Two-week, Four-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)
Time frame: One-week, Two-week, Four-week post-WMT