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NCT07060118 · ClinicalTrials.gov registry record · NA

Gluten Free Diet in Hashimoto's Hypothyroidism

A NA study of Hypothyroidism and Hashimoto Disease, sponsored by The Cleveland Clinic.

Recruiting
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT07060118: Recruiting NA study of Hypothyroidism and Hashimoto Disease, sponsored by The Cleveland Clinic.

NCT07060118 is a NA study of Hypothyroidism and Hashimoto Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 823-participant average among 9 other Hypothyroidism trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07060118, a NA study of Hypothyroidism and Hashimoto Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

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 c

Primary Outcome

Change in quality-of-life metrics

Interventions

  • DIETARY_SUPPLEMENT Gluten Free Diet in Hashimoto's Hypothyroidism

Study Locations (1)

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2025-07-15
Est. Completion 2026-06-30
Phase NA
The Cleveland Clinic

688 total trials

What NCT07060118 shows while recruiting

NCT07060118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 823-participant average among 9 other Hypothyroidism trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Hypothyroidism appearing as the primary indexed condition, and to 1 intervention - of which Gluten Free Diet in Hashimoto's Hypothyroidism is the first listed.

NCT07060118 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT07060118 about?

NCT07060118 is a clinical study titled "Gluten Free Diet in Hashimoto's Hypothyroidism". 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 ...

What is the current status of trial NCT07060118?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-07-15. Estimated completion is 2026-06-30.

What conditions does trial NCT07060118 study?

This clinical trial studies the following conditions: Hypothyroidism, Hashimoto Disease.

What interventions are being tested in trial NCT07060118?

The interventions under investigation include: Gluten Free Diet in Hashimoto's Hypothyroidism (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT07060118?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07060118 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hypothyroidism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07060118's enrollment target sits among peer trials

50 8th of 9 higher than 2 of 9 other Hypothyroidism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypothyroidism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07060118, the US trial registry maintained by the National Library of Medicine. NCT07060118 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.