Clinical trial NCT06256614: Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Official title: Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: washed microbiota transplantation
type 1 diabetes mellitus
glycemic variability
daily insulin dosage
hypoglycemia
insulin sensitivity
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National patients with T1DM receiving WMT will be enrolled.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

1. At the time of informed consent, male or non-pregnant or non-lactating female.
2. The diagnostic criteria for T1DM are confirmed by previous medical record.
3. 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.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

1. Diagnosed as any type of diabetes other than type 1 diabetes mellitus;
2. Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);
3. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
4. 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.

Primary outcomes:
measure: The mean daily insulin dosage of participants
timeFrame: One-week, Two-week, Four-week post-WMT
Secondary outcomes:
measure: The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The coefficient of variation (CV, percent) of type 1 diabetes mellitus.
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week
timeFrame: One-week, Two-week, Four-week post-WMT
measure: The islet β-cell function after WMT compared with baseline
timeFrame: Three-day, One-week, Two-week, Four-week post-WMT
measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
timeFrame: One-week, Two-week, Four-week post-WMT
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
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