Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

April 16, 2024 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

National patients with T1DM receiving WMT will be enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean daily insulin dosage of participants
Time Frame: One-week, Two-week, Four-week post-WMT
The mean daily insulin dosage of participants in past week
One-week, Two-week, Four-week post-WMT

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

February 4, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMT-RWS-T1DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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