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Gluten-Free diet may ease Hashimoto's symptoms, study finds

NCT ID NCT07060118

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a gluten-free diet can improve quality of life for people with Hashimoto's hypothyroidism who still have symptoms like brain fog and fatigue despite standard thyroid medication. About 50 adults with Hashimoto's will follow a gluten-free diet, and researchers will measure changes in their symptoms and well-being. The goal is to find a non-invasive way to reduce autoimmune-related inflammation and improve daily functioning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hashimoto thyroiditis hypothyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hashimoto disease Hypothyroidism

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.