Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06256614
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-02-04
• Study First Posted: 2024-02-13
• Study Start: 2024-03-01
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2029-01
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean daily insulin dosage of participants	One-week, Two-week, Four-week post-WMT	The mean daily insulin dosage of participants in past week

Secondary Outcome Measures

Name	Time	Method
The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol/L) over a 24-hour period
The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	The standard deviation of measured values during immediate blood glucose monitoring
The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	The range of blood glucose values observed during immediate blood glucose monitoring
The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	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
The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	The average absolute difference between corresponding measured values over a continuous 48-hour period
The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	The average absolute difference between post-meal blood glucose taken 2 hours after three meals and the corresponding pre-meal blood glucose.
The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	Average values obtained from immediate blood glucose monitoring
The coefficient of variation (CV, percent) of type 1 diabetes mellitus.	One-week, Two-week, Four-week post-WMT	CV=(SDBG÷MBG)×100%
The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week	One-week, Two-week, Four-week post-WMT	Hypoglycemia is defined as blood glucose \< 3.9 mmol/L
The islet β-cell function after WMT compared with baseline	Three-day, One-week, Two-week, Four-week post-WMT	2-hour postprandial C-peptide release was used to reflect islet β-cell function
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0	One-week, Two-week, Four-week post-WMT	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.)

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China