deltatrials
Recruiting INTERVENTIONAL NCT07060118

Gluten Free Diet in Hashimoto's Hypothyroidism

Gluten Free Diet For Treatment of Symptoms of Hashimoto's Hypothyroidism

Sponsor: The Cleveland Clinic

Updated 3 times since 2025 Last updated: Apr 14, 2026 Started: Jul 15, 2025 Primary completion: Aug 1, 2026 Completion: Dec 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07060118, this observational or N/A phase trial focuses on Hashimoto Disease and Hypothyroidism and remains actively recruiting participants. Sponsored by The Cleveland Clinic, it has been updated 3 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Researchers postulate increased intestinal permeability in those with NCGS exposed to gluten leading to immune activation and propagation of autoimmunity on the thyroid. Hence, elimination of gluten in diet may improve the autoimmunity and inflammation association with Hashimoto's thyroiditis, leading to improvement in negative symptoms such as the fatigue and brain fog.

Researchers postulate increased intestinal permeability in those with NCGS exposed to gluten leading to immune activation and propagation of autoimmunity on the thyroid. Hence, elimination of gluten in diet may improve the autoimmunity and inflammation association with Hashimoto's thyroiditis, leading to improvement in negative symptoms such as the fatigue and brain fog.

Status Flow

~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshotRecruiting~Oct 2025 – ~Apr 2026 · 6 months · monthly snapshotRecruitingApr 16, 2026 – present · 4 months · daily APIRecruiting

Change History

3 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Oct 2025 — Apr 2026 [monthly]

    Recruiting NA

  3. Aug 2025 — Oct 2025 [monthly]

    Recruiting NA

    First recorded

Jul 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

Hashimoto's thyroiditis is an autoimmune condition that reduces functioning of the thyroid gland and can lead to a substantial decline in quality of life for patients, with impacted patients often describing unremitting brain fog, fatigue/malaise and weight gain leading to difficulty functioning in their jobs and homes. It is the most common cause of hypothyroidism in the U.S. and affects up to 10% of the global population. The typical treatment for Hashimoto's is thyroid hormone replacement with medications such as levothyroxine. However, despite adequate treatment as defined by thyroid hormone levels within the reference range, up to 10% of patients will experience persisting symptoms which can dramatically impair quality of life. While various theories have been postulated for the residual symptoms, several studies indicate that they are related to the thyroid autoimmunity, specifically the autoantibodies that are made by the immune system in Hashimoto's thyroiditis in response to the thyroid (ie thyroid peroxidase \[TPO\], thyroglobulin \[Tg\] antibody \[AB\]) and the associated inflammation with the immune response. Removal of thyroid (ie total thyroidectomy) reduces levels of these thyroid antibodies and results in significant improvement in quality-of-life. However, thyroidectomy is an invasive procedure with potential for morbidity such as damage to the recurrent laryngeal (nerve that controls the vocal cords and thus speech), bleeding and infection, so there is interest in other more conservative modalities for lowering the inflammation and autoimmune burden in Hashimoto's thyroiditis. In an effort to identify a less invasive approach for reducing the levels of thyroid antibodies and inflammation, attention has moved to the intersection of Hashimoto's thyroiditis and the gut. Hashimoto's has a strong association with autoimmune disorders impacting the gastrointestinal tract, in particular celiac disease and non-celiac gluten sensitivity (NCGS). NCGS is a condition where there are intestinal and extra-intestinal symptoms associated the consumption of gluten but no presence of anti-tissue transglutaminase antibodies (anti-tTG) which define Celiac Disease. This connection between Hashimoto's thyroiditis and sensitivity to gluten appears to be not only genetic, as those with Celiac Disease/NCGS and Hashimoto's thyroiditis have common HLA haplotypes, but also at the level of the intestine with gut microbiome dysfunction.

Contact Information

Sponsor contact:
  • The Cleveland Clinic
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations