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Active, not recruitingNCT07060118Updated Sep 29, 2026

Gluten Free Diet in Hashimoto's Hypothyroidism

An interventional study of Gluten Free Diet in Hashimoto's Hypothyroidism in Hypothyroidism and Hashimoto Disease, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention

Updated Sep 29, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Hypothyroidism
  • Hashimoto Disease
03

In context

Hypothyroidism

247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.

This study's planned enrollment of 50 is below the median of 78 across 128 interventional studies indexed under Hypothyroidism.

Browse Hypothyroidism studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Gluten Free Diet in Hashimoto's Hypothyroidism

    Dietary Supplement: Gluten Free Diet in Hashimoto's Hypothyroidism

Interventions

  • Dietary supplementGluten Free Diet in Hashimoto's Hypothyroidism

    Gluten Free Diet in patients with Hashimoto's Hypothyroidism

06

What researchers measure

Primary outcomes

  1. Primary outcome

    Change in quality-of-life metrics

    Time frame: 6 months

Other outcomes

  1. Outcome measure #2

    Change in thyroid autoantibody titers and hormone levels

    Time frame: 6 months

  2. Outcome measure #3

    Adherence to gluten free diet

    Time frame: 6 months

  3. Outcome measure #4

    Correlation of baseline in wheat/gluten proteome reactivity and autoimmunity levels with response to a gluten free diet in terms of thyroid indices and quality-of-life metrics.

    Time frame: 6 months

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 1, 2026→Oct 1, 2026
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Aug 1, 2026→Oct 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07060118
Lead sponsor
The Cleveland Clinic
Responsible party
Keren Zhou (Research Director, The Cleveland Clinic) — Principal investigator
First posted
Jul 11, 2025
Start date
Jul 15, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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