NCT06249074

Gluten-free Diet in Women With Autoimmune Thyroiditis

Completed NA Last updated 8 February 2024

What this trial tests

NA trial testing Gluten-free diet in Autoimmune Thyroiditis in 31 participants. Completed in 30 November 2021.

Timeline

22 September 2020

Primary endpoint
16 November 2021

30 November 2021

Quick facts

Lead sponsor	Medical University of Gdansk
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	31
Start date	22 September 2020
Primary completion	16 November 2021
Estimated completion	30 November 2021
Sites	1 location across Poland

Drugs / interventions tested

• Gluten-free diet
• Gluten capsules supplementation
• Placebo capsules supplementation

Conditions studied

• Autoimmune Thyroiditis — all drugs for Autoimmune Thyroiditis →

Sponsor

Medical University of Gdansk

Who can join

Adults 20 to 50, female only, with Autoimmune Thyroiditis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gluten-Free Diet Alters the Gut Microbiome in Women with Autoimmune Thyroiditis.
   Rodziewicz A, Szewczyk A, Bryl E. · · 2024 · cited 5× · PMID 38474814 · DOI 10.3390/nu16050685
2. Effects of Gluten-Free Diet in Non-Celiac Hashimoto's Thyroiditis: A Systematic Review and Meta-Analysis.
   Araújo EMQ, Coutinho-Lima CRO, Sousa AS, Souza LMS, et al · · 2025 · cited 1× · PMID 41228508 · DOI 10.3390/nu17213437