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NCT Number: NCT06256614

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location status: Recruiting

Location contact

Faming Zhang, MD, PhD

CONTACT

[email protected]

086-25-58509883

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.

Exclusion criteria

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

  • 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.

Treatment and study plan

WMT

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. The Blood glucose of Time in Range (TIR, percent) 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. The coefficient of variation (CV, percent) of type 1 diabetes mellitus.

    Time frame: One-week, Two-week, Four-week post-WMT

    CV=(SDBG÷MBG)×100%

  9. 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

  10. 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

  11. 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Bota Cui

CONTACT

[email protected]

086-025-58509884

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 13, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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