An observational study in Type 1 Diabetes, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 3 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
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).
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 50 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
National patients with T1DM receiving WMT will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following inclusion criteria to enter the study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The mean daily insulin dosage of participants
The mean daily insulin dosage of participants in past week
Time frame: One-week, Two-week, Four-week post-WMT
The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.
The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol/L) over a 24-hour period
Time frame: One-week, Two-week, Four-week post-WMT
The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.
The standard deviation of measured values during immediate blood glucose monitoring
Time frame: One-week, Two-week, Four-week post-WMT
The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus.
The range of blood glucose values observed during immediate blood glucose monitoring
Time frame: One-week, Two-week, Four-week post-WMT
The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.
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
Time frame: One-week, Two-week, Four-week post-WMT
The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.
The average absolute difference between corresponding measured values over a continuous 48-hour period
Time frame: One-week, Two-week, Four-week post-WMT
The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.
The average absolute difference between post-meal blood glucose taken 2 hours after three meals and the corresponding pre-meal blood glucose.
Time frame: One-week, Two-week, Four-week post-WMT
The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.
Average values obtained from immediate blood glucose monitoring
Time frame: One-week, Two-week, Four-week post-WMT
The coefficient of variation (CV, percent) of type 1 diabetes mellitus.
CV=(SDBG÷MBG)×100%
Time frame: One-week, Two-week, Four-week post-WMT
The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week
Hypoglycemia is defined as blood glucose \< 3.9 mmol/L
Time frame: One-week, Two-week, Four-week post-WMT
The islet β-cell function after WMT compared with baseline
2-hour postprandial C-peptide release was used to reflect islet β-cell function
Time frame: Three-day, One-week, Two-week, Four-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
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.)
Time frame: One-week, Two-week, Four-week post-WMT
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Jan 2029, 58 months after the start.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 58 months is above that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Second Hospital of Nanjing Medical University