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ID
Source
Brief title
Health condition
subclinical hypothyroidism
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess and compare the difference in thyroid gland secretion capacity by measuring maximal FT4 and FT3 response upon intramuscular administration of 0.9mg Thyrogen assessed by AUC0-48hours in subclinical hypothyroid subjects and healthy controls after thyroid stimulation and before and after a short term antibiotics course.
Secondary outcome
Secondary objectives will be influence of gut microbiome on thyroid hormone metabolism and effect of thyroid hormone stimulation on inflammatory status after thyroid stimulation and before and after a short term antibiotics course.
- Gut microbiome composition:
- To assess and compare changes in the gut microbiome composition between SCT subjects and healthy controls at baseline.
- In addition, microbiota composition (and their plasma metabolites) will be determined and compared upon thyroid hormone stimulation and before and after a short term oral antibiotics course.
- Thyroid hormone metabolism:
- To assess and compare changes of fecal excretion of T4 and T3 in SCT subjects and healthy controls before and after thyroid hormone stimulation.
- In addition, we will determine changes of fecal excretion of T4 and T3 before and after a short term antibiotics course.
- Quality of life will be determined by ThyPro questionnaire
- Immunologic parameters: based on FACS on peripheral blood mononuclear cells (Th1, Th2, Th17, Treg, B cells), cytokines and markers of thyroid autoimmunity (anti-TPO antibodies) in SCT subjects as compared to healthy controls at 0h, 5h and 48h after thyroid stimulation and before and after a short term antibiotics course.
- Intestinal transit time
- Evaluate the differences of intestinal transit time as assessed by radiopaque makers between SCT subjects and healthy controls.
Background summary
A better understanding of the (patho)physiological pathway of the gut microbiome involvement in thyroid hormone metabolism and residual thyroid function in autoimmune hypothyroidism is needed . in this study we aim to validate a dynamic thyroid function test to assess thyroid reserve capacity ( by measuring maximal serum FT4 and FT3 response upon a single intramuscular administration of 0.9 mg r-TSH). Moreover, we aim to evaluate the effect of the gut microbiome changes on thyroid hormone metabolism in subclinical autoimmune hypothyroid subjects by assessing and comparing changes of plasma and faecal levels T4 and T3 upon the Thyrogen stimulation and a short course of antibiotics in 20 subjects ( 10 subclinical autoimmune hypothyroid patients (medication naïve) and 10 matched healthy controls).
Study objective
residual thyroid function is altered by short term oral antibiotic treatment in subclinical hypothyroid subjects as compared to healthy controls.
Study design
day 0-2 and 21-23 (reproducibility of residual thyroid function test) as well as after oral antibiotics (day 44-46)
Intervention
rTSH injections for residual thyroid function. Moreover, one week with oral metronidazole (500 mg twice daily) plus ciprofloxacin (500 mg once daily), plus oral vancomycine (500mg four times daily).
Inclusion criteria
Healthy controls:
- Caucasian
- 35 – 70 years
- BMI 18 – 30 kg/m2
- Able to give informed consent
subclinical hypothyroidism:
- Caucasian
- 35 – 70 years
- BMI 18 – 30 kg/m2
- Able to give informed consent
- Recent diagnosis of subclinical hypothyroidism: TSH ≥ 10 mU/L, FT4 within normal range and anti-TPO positive
Exclusion criteria
For all subjects:
- Use of any medication including levothyroxine, proton pump inhibitors, antibiotics and pro-/ probiotics in the past three months
- Diagnosis or symptoms of other autoimmune disease (e.g. T1D, coeliac, rheumatoid arthritis or inflammatory bowel disease like Crohn and colitis ulcerosa)
- History of cholecystectomy
- Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period
- Pregnant or lactating women
- Previous intestinal (e.g., bowel resection/reconstruction) surgery
- Chronic illness (including a known history of heart failure, renal failure (eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8925 |
| Other | METC AMC : 2020-140 |