NCT06249074

Gluten-free Diet in Women With Autoimmune Thyroiditis

The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition. The main questions it aimed to answer were: * Does the gluten-free diet worsen the gut microbiome composition? * Does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)? * Does the gluten-free diet improve the quality of life? Participants: * followed normocaloric gluten-free diet for 8 weeks * after first 4 weeks were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo). Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks of diet (T2) (total of 3 samples per participant). Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).

Conditions

• Autoimmune Thyroiditis

Interventions

Type	Name	Description
OTHER	Gluten-free diet	Diet with gluten elimination followed by all participants for 8 weeks
OTHER	Gluten capsules supplementation	2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
OTHER	Placebo capsules supplementation	Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-11-16
• Completion: 2021-11-30
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: Poland