Effect of donor Intestinal Microbiota Infusion on Thyroid function in patients with subclinical autoimmune Hypothyroidism.
Not Applicable
Recruiting
- Conditions
- <p>hypothyrodism</p>10043739
- Registration Number
- NL-OMON23348
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
- diagnosis of autoimmune hypothyroidism - age 18-70 years, BMI 18-30 kg/m2, male/females - antiTPO positive and increased TSH (above 10mE/L) with FT4 within normal reference value.
Exclusion Criteria
- presence of other autoimmune disease (eg type 1 diabetes, coeliac, rheumatoid arthritis or inflammatory bowel disease like Crohn/colitis ulcerosa) - antibiotics and PPI use use in the last 3 months - (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary effect parameter is the preserving (Thyrogen stimulated) fT4 and fT3 release at 6, 12, and 24 months compared with baseline (0 months). This dynamic thyroid functional endpoint is chosen because Thyrogen acts as an amplifier, which can magnify any underlying abnormality in thyroid hormone secretion by the thyroid gland, making it possible to detect subtle changes in thyroid functioning. Moreover, static thyroid serum markers (e.g., a single, fasted measurement) could be affected by external factors, such as seasonal variation, the timing of blood draw, exercise, diet and lifestyle, and BMI. In a dynamic function test measuring the net incremental increase in the AUC, these factors may have less influence on the results. </p><br>
- Secondary Outcome Measures
Name Time Method