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The Adjuvant Therapeutic Effect and Mechanism of Lactobacillus Acidophilus LA-06 in the Treatment of Newly Diagnosed Graves' Disease

The Adjuvant Therapeutic Effect and Mechanism of Lactobacillus Acidophilus LA-06 in the Treatment of Newly Diagnosed Graves' Disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112233
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-02-12
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Graves disease

Interventions

Placebo group A:methimazole
LA-06 group B:methimazole+Lactobacillus acidophilus06

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Symptoms and signs of hyperthyroidism;2. Diffuse thyroid enlargement;3. Decreased serum TSH levels with elevated TT3, FT3, TT4, and FT4;4.Exophthalmos and other infiltrative eye signs;5. Pretibial myxedema;6. Positive TSH receptor antibody (TRAb).Among the above criteria:Items 1-3 are mandatory for diagnosis.Items 4-6 are supportive diagnostic criteria. The patient agrees to participate in this study and signs the informed consent form. The patient is conscious and able to cooperate in completing examinations, questionnaires, medical history collection, etc., either independently or with the assistance of family members.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating patients 2.Patients with severe cognitive impairment that affects written and verbal expression, severe aphasia, or dysphasia; 3 . Patients with neurological and psychiatric disorders (degenerative and/or vascular dementia, Parkinson's disease, stroke, and severe depression), severe multi-organ diseases (anemia, lung diseases, cancer) that affect cognition; 4. Patients with other severe physical illnesses or severe abnormalities in liver and kidney function; 5. Patients requiring long-term use of immunosuppressants or those who have taken antibiotics within one month prior to enrollment and during follow-up; 6. Patients who discontinued or arbitrarily adjusted the test sample during follow-up; 7. Patients who concurrently used laxatives such as polyethylene glycol electrolyte, phenolphthalein tablets, senna leaves, etc., during follow-up; 8. Patients with chronic digestive system diseases or tumors, such as peptic ulcer, inflammatory bowel disease, severe liver disease, etc.; 9. Patients who are allergic to the test sample or experience intolerable gastrointestinal symptoms 10. Patients with irregular dietary habits or significant changes in diet during follow-up.

Design outcomes

Primary

MeasureTime frame
quality of life;

Secondary

MeasureTime frame
Intestinal function;cognitive ability;Sleep condition;Anxiety;Depression;

Countries

China

Contacts

Public ContactChi Haiyan

Weihai Municipal Hospital

drzhangjinbiao@163.com+86 186 6037 8456

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026