Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

NCT06256614 | Recruiting DMC

• 1 other identifier: WMT-RWS-T1DM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

washed microbiota transplantation; type 1 diabetes mellitus; glycemic variability; daily insulin dosage; hypoglycemia; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• The mean daily insulin dosage of participants

  The mean daily insulin dosage of participants in past week

  One-week, Two-week, Four-week post-WMT

Secondary Outcomes (11)

• The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.

  One-week, Two-week, Four-week post-WMT

• The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.

  One-week, Two-week, Four-week post-WMT

• The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.

  One-week, Two-week, Four-week post-WMT

• The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.

  One-week, Two-week, Four-week post-WMT

• The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.

  One-week, Two-week, Four-week post-WMT

Interventions

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.

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National patients with T1DM receiving WMT will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

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Related Links

• The top 10 causes of death. World Health Organization.
• Diabetes Facts and Figures. International Diabetes Federation.

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal, urine, and blood samples before and after intervention

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

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

Bota Cui

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 13, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)