Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis
Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are:
Can FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect.
Participants will:
Complete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Xu Jun Shen
- Telefonnummer: +8615906675015
- E-post: sxjsandy@126.com
Studer Kontakt Backup
- Navn: Ling Ling Zhang
- Telefonnummer: +8619706851581
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 and ≤ 65 years old.
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.
- The regimens of hypoglycemic drugs and thyroid-related basic treatments (including drug types and dosages) have remained stable for at least 3 months before enrollment.
Exclusion Criteria:
- Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.
- Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).
- Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.
- Patients with severe immunosuppression (neutrophil count < 1500/mm³, lymphocyte count < 500/mm³).
- Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier/mucosal injury.
- Patients with intestinal mucosal injury of unknown etiology.
- Patients diagnosed with fulminant colitis or toxic megacolon.
- Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.
- Severe malnutrition (body mass index < 15 kg/m²) or severe hypoalbuminemia (serum albumin < 25 g/L).
- Congenital or acquired immunodeficiency diseases.
- Patients who have recently received high-risk immunosuppressants or cytotoxic drugs (e.g., rituximab, doxorubicin), or medium-to-high dose glucocorticoids (e.g., prednisone >= 20 mg per day for more than 4 consecutive weeks).
- Patients complicated with other autoimmune diseases.
- Patients with severe hepatic or renal insufficiency.
- Patients with malignant tumors.
- Patients with known allergy to capsule ingredients.
- Pregnant or lactating females.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fecal microbiota transplantation group
|
All subjects received a single standardized fecal microbiota transplantation (FMT) intervention at Week 0 under unified protocols.
After fasting, each subject took 40 standardized fecal microbiota suspension capsules in divided doses within 1.5 hours (2-3 capsules each time, swallowed with warm water).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Glycated Hemoglobin(HbA1c)
Tidsramme: baseline，week 12，week 24
|
baseline，week 12，week 24
|
|
Fasting blood glucose
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
2-hour postprandial blood glucose
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Thyroid Peroxidase Antibody(TPOAb)
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Thyroglobulin Antibody(TgAb)
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Recovery of characteristic gut microbiota
Tidsramme: baseline，week 12，week 24
|
baseline，week 12，week 24
|
|
Triglycerides
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Total cholesterol
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Uric acid
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Fasting Insulin
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
|
Body weight
Tidsramme: baseline，week12，week24
|
baseline，week12，week24
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Zhelvyi Ethics【2026】No.12
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Only qualified clinical research investigators may submit formal written data access applications to the principal investigator.
Approved applicants can obtain de-identified individual participant data, study protocol, statistical analysis plan and informed consent form.
Data will be delivered via encrypted electronic files after signing a data use agreement.
Data application requests shall be submitted by email to the principal investigator; there is no dedicated public web portal for online application.
All data access inquiries and completed application documents should be sent to the principal investigator via official email.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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