Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT07060118
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07060118
Study Brief:
Protocol Section:
NCT07060118