hypothyrodism thyroid disease
Conditions
Interventions
fecal transplantation from either allogenic healthy donors or own (autologous)
will be given three times (baseline, 8 and 16 weeks) via a small intestinal
tube
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Newly diagnosed patients with subclinical autoimmune hypothyroidism aged 18-70 years, TSH > 10 mU/L BMI 18-30 kg/m2, male/females, no concomitant medication, antiTPO positive and increased TSH (above 5.0mE/L) with FT4 within normal reference value ;feces donoren: Healthy male/female volunteers aged 18-70 years, BMI 18-28 kg/m2, no medication use, no family history of autoimmune diseases
Exclusion criteria
Exclusion criteria: concomitant medication including PPI and antibiotics past three months, smoking, (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is effect on residual thyroid function as determined by plasma thyroid markers (TSH/FT4 and antiTPO) as well as determined by rTSH test (0.9mg intramuscular injection) at baseline, 6, 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are reduction in autoimmunity makers including FACS on peripheral blood lymfocyte subsets (change Th17 (CD4+IL-17+) and T-regs (CD4+CD25+ FoxP3+) and in FNAC thyroid (for Imaging Mass Spectrometry) at baseline and after 6 and 24 months. Moreover, intestinal transit time (Sitzmark capsules) will be determined at these three timepoints. Also, quality of life questionnaires ( ThyPro, a disease specific QoL scale) and dietary intake lists online (via mijn.voedingscentrum.nl/nl/eetmeter) are measured at 0, 6, 12 and 24 months. Finally, oral and fecal intestinal microbiota and plasma metabolite are determined at 0, 6, 12 and 24 months. | — |
Countries
Netherlands
Outcome results
None listed