Effect of donor Intestinal Microbiota Infusion on Thyroid function in patients with autoimmune HypOThyreoidism

Recruiting

Conditions: hypothyrodism
thyroid disease
10043739

Registration Number: NL-OMON48031

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 51

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

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 < 240).;fecal donors:
1. (chronic) diarrhoea
2. family history of autoimmune diseases (type 1 diabetes, Hashimoto hypothyreoidism, Graves hyperthyreoidism, rheumatoid arthritis, inflammatory bowel diseases eg. Crohn*s disease, Colitus ulcerosa or coeliakie)
3. HIV, HAV, HBV, HCV, active CMV, active EBV
4. Unsafe sex practice (questionnaire)
5. presence of fecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia) or parasites
6. positive C. difficile stool test
7. any medication use including PPI and antibiotics
8. smoking

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is effect on residual thyroid function as determined by<br /><br>plasma thyroid markers (TSH/FT4 and antiTPO) as well as determined by rTSH test<br /><br>(0.9mg intramuscular injection) at baseline, 6, 12 and 24 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are reduction in autoimmunity makers including FACS on<br /><br>peripheral blood lymfocyte subsets (change Th17 (CD4+IL-17+) and T-regs<br /><br>(CD4+CD25+ FoxP3+) and in FNAC thyroid (for Imaging Mass Spectrometry) at<br /><br>baseline and after 6 and 24 months. Moreover, intestinal transit time (Sitzmark<br /><br>capsules) will be determined at these three timepoints. Also, quality of life<br /><br>questionnaires ( ThyPro, a disease specific QoL scale) and dietary intake lists<br /><br>online (via mijn.voedingscentrum.nl/nl/eetmeter) are measured at 0, 6, 12 and<br /><br>24 months. Finally, oral and fecal intestinal microbiota and plasma metabolite<br /><br>are determined at 0, 6, 12 and 24 months.</p><br>