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Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

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

NCT06256614•The Second Hospital of Nanjing Medical University

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

Age

3 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.

Locations (1)

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

Nanjing, Jiangsu, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

January 1, 2029

Completion Date

July 1, 2029

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Type 1 Diabetes

Interventions

WMT

OTHER

Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883 fzhang@njmu.edu.cn

Bota Cui

CONTACT

086-025-58509884 cuibota@njmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

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