type 1 diabetes mellitus
Conditions
Interventions
Intervention group:Intestinal microbiota extract capsules
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed with T1DM by an endocrinologist, with a over 1-year duration of T1DM; 2. Aged 18–60 years; 3. HbA1c 7.0–14.0% or TIR =3 months; 5. Total daily insulin dose =0.3 IU/kg/day, with a basal rate >=0.05 IU/hour prior to study recruitment; 6. Women of childbearing potential willing to use appropriate contraception; 7. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Use of any glucose-lowering medications other than insulin; 2. Continuous use of antimicrobial agents, probiotics, intestinal microecological regulators, or other drugs with potential impact on gut microbiota for >3 days within 3 months prior to enrollment; 3. Occurrence of acute diabetic complications (diabetic ketoacidosis [DKA], hyperosmolar hyperglycemic state) within 1 month prior to enrollment; 4. Comorbid gastrointestinal diseases (including but not limited to persistent vomiting, confirmed/suspected gastrointestinal obstruction, short bowel syndrome, inflammatory bowel disease, active massive gastrointestinal bleeding, gastrointestinal perforation, high-output intestinal fistula, severe diarrhea, significant fibrotic intestinal strictures, fulminant colitis, or toxic megacolon), history of gastrointestinal surgery (e.g., gastrectomy, pelvic floor anastomosis, colostomy, or other digestive system surgeries), malignancy, or sepsis; 5. Comorbid severe cardiovascular or cerebrovascular diseases, hepatic, renal, or hematopoietic system disorders, severe immunosuppression, or congenital/acquired immunodeficiency diseases; 6. Recent use of high-risk immunosuppressive or cytotoxic medications: e.g., rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (prednisone >=20 mg/day) for more than 4 weeks; 7. Use of closed-loop systems or sensor-augmented pump therapy within 3 months prior to enrollment; 8. Concurrent participation in another RCT; 9. Pregnancy, lactation, or women planning pregnancy during the study period; 10. Inability to adhere to the recommended intervention and follow-up schedule for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite achievement rate of time in range>70% and time below range <4%; | — |
Secondary
| Measure | Time frame |
|---|---|
| glycated hemoglobin;fasting glucose;mixed meal test 2h postprandial glucose;fasting c peptide;mixed meal test 2h postprandial C peptide;eGDR;Treg/Th17 ratio;cytokines;WBC;CRP;ESR;PCT;Abundance of Akkermansia; Abundance of Roseburia;short-chain fatty acids;lipid profile(TC,TG,HDL,LDL);total daily insulin dosage;CHFSII-WS score;DDS;EQ-5D-5L; | — |
Countries
China
Contacts
Public ContactZhe Dai
Zhongnan Hospital of Wuhan University
Outcome results
None listed