Type 1 DiabetesNCT06256614
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
An observational study of Type 1 Diabetes, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- WMT
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: National patients with T1DM receiving WMT will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research
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).
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- WMT
- Keywords
- washed microbiota transplantation, type 1 diabetes mellitus, glycemic variability, daily insulin dosage, hypoglycemia, insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WMTOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean daily insulin dosage of participants
The mean daily insulin dosage of participants in past week
Measured: 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.
The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol/L) over a 24-hour period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: One-week, Two-week, Four-week post-WMT
The coefficient of variation (CV, percent) of type 1 diabetes mellitus.
CV=(SDBG÷MBG)×100%
Measured: 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
Measured: 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
Measured: 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.)
Measured: One-week, Two-week, Four-week post-WMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2024
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256614
- Sponsor's protocol ID
- WMT-RWS-T1DM
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34962526Li 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.
PubMed 32345662Guideline 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.
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.
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.
PubMed 36817869Zhong 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.
PubMed 37523704Experts consensus on management of glycemic variability of diabetes mellitus. Chin J Endocrinol Metab. 2017;33(8):633-636.
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.
PubMed 10333939Su 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.
PubMed 21349201Su 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.
PubMed 23349547Jin 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.
PubMed 25307609Hsu 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.
PubMed 25534877Surawicz 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.
PubMed 23439232Sampson 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.
PubMed 27912057Frost 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.
PubMed 33168600
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research
- ClinicalTrials.gov ID
- NCT06256614
- Acronym / sponsor ID
- WMT-RWS-T1DM
- Conditions
- Type 1 Diabetes
- Keywords
- washed microbiota transplantation, type 1 diabetes mellitus, glycemic variability, daily insulin dosage, hypoglycemia, insulin sensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- National patients with T1DM receiving WMT will be enrolled.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WMTWashed 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. | Other | – |
Primary outcome
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
11 secondary outcomes
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 SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
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 mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
The coefficient of variation (CV, percent) of type 1 diabetes mellitus.
Time frame: One-week, Two-week, Four-week post-WMT
The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week
Time frame: One-week, Two-week, Four-week post-WMT
The islet β-cell function after WMT compared with baseline
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
Time frame: One-week, Two-week, Four-week post-WMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 34962526Wang 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.
- Background: PubMed 32345662Li 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.
- BackgroundGuideline 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.
- BackgroundGuideline 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.
- Background: PubMed 36817869Liu 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.
- Background: PubMed 37523704Zhong 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.
- BackgroundExperts consensus on management of glycemic variability of diabetes mellitus. Chin J Endocrinol Metab. 2017;33(8):633-636.
- Background: PubMed 10333939Coutinho 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.
- Background: PubMed 21349201Su 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.
- Background: PubMed 23349547Su 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.
- Background: PubMed 25307609Jin 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.
- Background: PubMed 25534877Hsu 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.
- The top 10 causes of death. World Health Organization.Link provided by the sponsor.
- Diabetes Facts and Figures. International Diabetes Federation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faming Zhang, PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean daily insulin dosage of participants (time frame: One-week, Two-week, Four-week post-WMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256614, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.