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Mechanistic Study on the Regulation of Gut Microbiota and Its Metabolite Short-Chain Fatty Acids by Jianpi Yishen Huatan Formula in Improving Immune Imbalance in Hashimoto's Thyroiditis via the "Gut-Thyroid Axis"

Mechanistic Study on the Regulation of Gut Microbiota and Its Metabolite Short-Chain Fatty Acids by Jianpi Yishen Huatan Formula in Improving Immune Imbalance in Hashimoto's Thyroiditis via the "Gut-Thyroid Axis"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000879
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hashimoto's Thyroiditis

Interventions

Treatment group:Jianpi Yishen Huatan Formula granules

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Basic Information Requirements (1) Age: 18-65 years old; (2) Gender: No restriction. 2. Disease Diagnosis and Laboratory Indicators (1) Diagnostic Criteria: 1) Meeting the Western medicine diagnostic criteria for Hashimoto's Thyroiditis (HT); 2) Meeting the traditional Chinese medicine (TCM) syndrome differentiation criteria. (2) Key Biochemical Indicators: 1) Non-obese Body Mass Index (BMI) (18–30 kg/m²); 2) Abnormal results in at least three consecutive blood tests, with an interval of at least 3 months between the second and first tests; 3) No prior pharmacological treatment, relatively high serum Thyroid-Stimulating Hormone (TSH) levels, and positive Thyroid Peroxidase Antibody (TPOAb). (4) The sum of primary symptom scores is = 4 points, and the total syndrome score is = 8 points. 3. Voluntary participation and signing of the informed consent form, with a commitment to cooperate in completing the entire study period.

Exclusion criteria

Exclusion criteria: 1)Diagnosis or symptoms of other autoimmune diseases (e.g., type 1 diabetes, celiac disease, autoimmune gastritis, rheumatoid arthritis, or inflammatory bowel disease such as Crohn's disease and ulcerative colitis). 2)Use of any medications, including proton pump inhibitors, antibiotics, and probiotics/prebiotics, within the past 3 months or during the study period. 3)History of chronic diarrhea (=3 bowel movements per day for more than 4 weeks), chronic constipation ( 2 times the upper limit of normal), renal insufficiency (eGFR < 60 mL/min/1.73 m²), hematologic disorders, or psychiatric diseases. 7)Pregnancy, lactation, or plans to become pregnant within the next 6 month

Design outcomes

Primary

MeasureTime frame
Peripheral blood Treg/Th17 ratio;

Secondary

MeasureTime frame
TPOAb;Microbiota Diversity;SCFAs;

Countries

China

Contacts

Public ContactZhou Zubang

Gansu Provincial Hospital

1308878848@163.com+86 139 1997 4821

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026