Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One-week, Two-week, Four-week post-WMT |
| The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus. |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
National patients with T1DM receiving WMT will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faming Zhang, PhD | Contact | 086-025-58509883 | fzhang@njmu.edu.cn | |
| Bota Cui | Contact | 086-025-58509884 | cuibota@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Faming Zhang, PhD | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34962526 | Background | Wang L, Peng W, Zhao Z, Zhang M, Shi Z, Song Z, Zhang X, Li C, Huang Z, Sun X, Wang L, Zhou M, Wu J, Wang Y. Prevalence and Treatment of Diabetes in China, 2013-2018. JAMA. 2021 Dec 28;326(24):2498-2506. doi: 10.1001/jama.2021.22208. | |
| 32345662 | Background | Li Y, Teng D, Shi X, Qin G, Qin Y, Quan H, Shi B, Sun H, Ba J, Chen B, Du J, He L, Lai X, Li Y, Chi H, Liao E, Liu C, Liu L, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Teng W, Shan Z. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ. 2020 Apr 28;369:m997. doi: 10.1136/bmj.m997. |
| Label | URL |
|---|---|
| The top 10 causes of death. World Health Organization. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
fecal, urine, and blood samples before and after intervention
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. | 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. | 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. | 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. | 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. | Average values obtained from immediate blood glucose monitoring | One-week, Two-week, Four-week post-WMT |
| The coefficient of variation (CV, percent) of type 1 diabetes mellitus. | 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 | Hypoglycemia is defined as blood glucose < 3.9 mmol/L | 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 | 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.) | One-week, Two-week, Four-week post-WMT |
| Background | Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)(Part 1). Chinese Journal of Practical Internal Medicine. 2020;41(8):668-695. |
| Background | Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)(Part 2). Chinese Journal of Practical Internal Medicine. 2020;41(9):757-784. |
| 36817869 | Background | Liu J, Liu M, Chai Z, Li C, Wang Y, Shen M, Zhuang G, Zhang L. Projected rapid growth in diabetes disease burden and economic burden in China: a spatio-temporal study from 2020 to 2030. Lancet Reg Health West Pac. 2023 Feb 3;33:100700. doi: 10.1016/j.lanwpc.2023.100700. eCollection 2023 Apr. |
| 37523704 | Background | Zhong VW, Yu D, Zhao L, Yang Y, Li X, Li Y, Huang Y, Ding G, Wang H. Achievement of Guideline-Recommended Targets in Diabetes Care in China : A Nationwide Cross-Sectional Study. Ann Intern Med. 2023 Aug;176(8):1037-1046. doi: 10.7326/M23-0442. Epub 2023 Aug 1. |
| Background | Experts consensus on management of glycemic variability of diabetes mellitus. Chin J Endocrinol Metab. 2017;33(8):633-636. |
| 10333939 | Background | Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care. 1999 Feb;22(2):233-40. doi: 10.2337/diacare.22.2.233. |
| 21349201 | Background | Su G, Mi S, Tao H, Li Z, Yang H, Zheng H, Zhou Y, Ma C. Association of glycemic variability and the presence and severity of coronary artery disease in patients with type 2 diabetes. Cardiovasc Diabetol. 2011 Feb 25;10:19. doi: 10.1186/1475-2840-10-19. |
| 23349547 | Background | Su G, Mi SH, Tao H, Li Z, Yang HX, Zheng H, Zhou Y, Tian L. Impact of admission glycemic variability, glucose, and glycosylated hemoglobin on major adverse cardiac events after acute myocardial infarction. Diabetes Care. 2013 Apr;36(4):1026-32. doi: 10.2337/dc12-0925. Epub 2013 Jan 24. |
| 25307609 | Background | Jin SM, Kim TH, Oh S, Baek J, Joung JY, Park SM, Cho YY, Sohn SY, Hur KY, Lee MS, Lee MK, Kim JH. Association between the extent of urinary albumin excretion and glycaemic variability indices measured by continuous glucose monitoring. Diabet Med. 2015 Feb;32(2):274-9. doi: 10.1111/dme.12607. Epub 2014 Oct 29. |
| 25534877 | Background | Hsu CR, Chen YT, Sheu WH. Glycemic variability and diabetes retinopathy: a missing link. J Diabetes Complications. 2015 Mar;29(2):302-6. doi: 10.1016/j.jdiacomp.2014.11.013. Epub 2014 Dec 3. |
| 23439232 | Background | Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26. |
| 27912057 | Background | Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018. |
| 33168600 | Background | Frost F, Kacprowski T, Ruhlemann M, Pietzner M, Bang C, Franke A, Nauck M, Volker U, Volzke H, Dorr M, Baumbach J, Sendler M, Schulz C, Mayerle J, Weiss FU, Homuth G, Lerch MM. Long-term instability of the intestinal microbiome is associated with metabolic liver disease, low microbiota diversity, diabetes mellitus and impaired exocrine pancreatic function. Gut. 2021 Mar;70(3):522-530. doi: 10.1136/gutjnl-2020-322753. Epub 2020 Nov 9. |
| 37451270 | Background | Yang J, Yang X, Wu G, Huang F, Shi X, Wei W, Zhang Y, Zhang H, Cheng L, Yu L, Shang J, Lv Y, Wang X, Zhai R, Li P, Cui B, Fang Y, Deng X, Tang S, Wang L, Yuan Q, Zhao L, Zhang F, Zhang C, Yuan H. Gut microbiota modulate distal symmetric polyneuropathy in patients with diabetes. Cell Metab. 2023 Sep 5;35(9):1548-1562.e7. doi: 10.1016/j.cmet.2023.06.010. Epub 2023 Jul 13. |
| 31919742 | Background | Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9. |
| 35576458 | Background | Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16. |
| Diabetes Facts and Figures. International Diabetes Federation. | View source |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |