As changes in gutmicrobiota composition could play a role in the development of autoimmune diseases including hypothyroidism, we will investigate whether repetitive fecal transplantation from either allogenic (healthy) or autologous (own) fecal…
ID
Bron
Verkorte titel
Aandoening
- Schildklieraandoeningen
Aandoening
hypothyrodism
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
effect on thyroid function as determined by plasma markers (TSH,T4, T3 and antiTPO levels) as well as residual thyroid function determined by rTSH test in relation to intestinal microbiota changes at baseline, 6, 12 and 24 months.
Achtergrond van het onderzoek
Altered gutmicrobiota composition seems to play a role in the development of autoimmune disease. We therefore aim to investigate whether microbial transplantation from either allogenic (healthy) or autologous (own) fecal donors has beneficial effects on thyroid function in recently diagnosed patients with autoimmune hypothyroidism.
Doel van het onderzoek
As changes in gutmicrobiota composition could play a role in the development of autoimmune diseases including hypothyroidism, we will investigate whether repetitive fecal transplantation from either allogenic (healthy) or autologous (own) fecal donors has beneficial effect on residual thyroid function in recently diagnosed patients with autoimmune hypothyroidism.
Onderzoeksopzet
0,6,12 and 24 months
Onderzoeksproduct en/of interventie
fecal transplantation
Publiek
Wetenschappelijk
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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).
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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Register | ID |
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NTR-new | NL7931 |
Ander register | METC AMC : 2019_045 |
CCMO | NL69382.018.19 |
OMON | NL-OMON48031 |