Gluten Free Diet in Hashimoto's Hypothyroidism

Launched by THE CLEVELAND CLINIC · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether following a gluten-free diet can help people with Hashimoto's thyroiditis, a common condition where the immune system attacks the thyroid gland. This condition often leads to low thyroid hormone levels, causing symptoms like tiredness, brain fog, and weight gain that can make daily life hard. Even when treated with thyroid hormone medicine, some people still have symptoms. Researchers want to see if a gluten-free diet can reduce the inflammation and immune system activity linked to Hashimoto’s, potentially improving symptoms and quality of life without needing surgery.

People who might join this study are adults diagnosed with Hashimoto’s thyroiditis who have been on thyroid hormone treatment for at least six months and have stable thyroid hormone levels. They also need to have certain antibodies in their blood that show their immune system is active against the thyroid, and they should feel that their quality of life is reduced because of their condition. Those who have had thyroid surgery, celiac disease, or have recently followed a gluten-free diet would not be eligible. Participants will be asked to follow a gluten-free diet during the study, and researchers will monitor their symptoms and antibody levels to see if the diet helps reduce inflammation and improve well-being.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Diagnosis of Hashimoto's thyroiditis
• • 2. Self-perception of reduced quality of life since diagnosis as determined by a ThyPRO score greater than or equal to 35 (higher score suggests lower quality-of-life) based on prior studies reporting of average score in individuals with symptomatic hypothyroidism.
• • 3. Hypothyroidism requiring use of thyroid hormone replacement \>6 months prior initiation of study
• • 4. Thyroid hormone levels (TSH, Free T4 and Free T3 as available) within the normal reference range within 3 months of the study initiation
• • 5. Anti-TPO AB greater than or equal to 500 IU/mL and/or Anti-Tg AB greater than or equal to 50 IU/mL at any point in medical history
• • Exclusion Criteria
• • 1. Prior surgical intervention on thyroid
• • 2. Prior Celiac Disease diagnosis or symptoms which are highly suggestive of undiagnosed Celiac Disease (i.e. chronic diarrhea, blood in stool, unintentional weight loss, family history, etc). In the case of the latter, patients will be directed to speak with their physician to consider screening before being considered for enrollment into the study.
• • 3. Pregnancy
• • 4. Use of gluten-free diet within prior 6 months
• • 5. Active malignancy undergoing treatment
• • 6. Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study