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The GUT2GD study

The GUT2GD study: do changes in the gut microbiome trigger Graves’ Disease? - GUT2GD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58146
Enrollment
199
Registered
2025-04-28
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves' Disease Graves' Disease, hyperthyroidism, overactive thyroid

Interventions

This study has no investigational product, the only invasive intervention is the venous blood draw.&nbsp

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject with GD must meet all of the following criteria:=18 years oldDiagnosis of GD according to specialized clinician Elevated TRAb levels above upper reference limit in laboratory used at diagnosisGD onset or recurrence diagnosed within the last 4 months prior to inclusionAbility to provide informed consentAbility to understand Dutch or English In order to be eligible to participate in this study, a non-autoimmune hyperthyroidism control subject must meet all of the following criteria:=18 years oldAbility to provide informed consentAbility to understand Dutch or EnglishDiagnosis of non-autoimmune hyperthyroidism (toxic adenoma or toxic multinodular goiter) according to specialized clinician  In order to be eligible to participate in this study, a healthy control subject must meet all of the following criteria:=18 years oldAbility to provide informed consentAbility to understand Dutch or EnglishConsider themselves healthy

Exclusion criteria

Exclusion criteria: A potential subject with GD or non-autoimmune hyperthyroidism who meets any of the following criteria will be excluded from participation in this study:Active infection at the time of inclusion Antibiotic or proton-pump inhibitor use in the last 3 monthsUnwillingness to donate feces, urine and/or bloodAbsence of large bowel (ie colostomy)Previous thyroidectomy or ablative treatment with radioactive iodineUse of the following drugs that can interfere with thyroid function:AmiodaroneLithiumIodine or iodide supplements PregnancyActive treatment of malignancy A potential healthy control who meets any of the following criteria will be excluded from participation in this study:Active infection at the time of inclusion Antibiotic or proton-pump inhibitor use in the last 3 monthsUnwillingness to donate feces, urine and/or bloodAbsence of large bowel (ie colostomy)Previous thyroidectomy or ablative treatment with radioactive iodineUse of the following drugs that can interfere with thyroid function:AmiodaroneLithiumIodine or iodide supplements ThiamazolLevothyroxineLiothyroninePregnancyActive treatment of malignancy

Design outcomes

Secondary

MeasureTime frame
Gut microbiome compositionDNA analysis for HLA subtype, specific polymorphisms associated with a higher risk of GD recurrence and specific polymorphisms associated with altered thyroid hormone metabolism. Identification of gut microbes that are potentially capable of triggering GD in the gut microbiome of GD patients using computational tools and validating the immune response to these microbes in vitro using patient-derived T-cells.Urinary iodide and thyroid hormone concentrations

Primary

MeasureTime frame
Fecal and plasma thyroid hormone concentrations.Concentrations of auto-antibodies against the thyroid receptor (TRAbs) in plasma

Countries

Netherlands

Contacts

Public ContactA.H. Spek

Amsterdam UMC

a.h.vanderspek@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)