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Completed

NCT Number: NCT06249074

Gluten-free Diet in Women With Autoimmune Thyroiditis

The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition.

The main questions it aimed to answer were:

* Does the gluten-free diet worsen the gut microbiome composition? * Does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)? * Does the gluten-free diet improve the quality of life?

Participants:

* followed normocaloric gluten-free diet for 8 weeks * after first 4 weeks were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo).

Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks of diet (T2) (total of 3 samples per participant). Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).

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Key information

Conditions

Autoimmune Thyroiditis Autoimmune Diseases Endocrine System Diseases Immune System Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Gdańsk

Gdansk, 80-210, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • autoimmune thyroiditis diagnosed by endocrinologist based on increased TPOAb and/or TgAb levels;
  • stabilized thyroid function, i.e. thyroid hormones within normal range;
  • BMI indicating correct body mass, i.e. within 18.5 - 24.9 kg/m^2.

Exclusion criteria

  • newly diagnosed autoimmune thyroiditis and unregulated thyroid hormones (hypothyroidism or hyperthyroidism);
  • concomitant celiac disease and / or wheat allergy;
  • gluten-free diet followed during 6 months prior to enrollment;
  • intestinal disorders;
  • antibiotic or probiotic therapy during 6 months prior to enrollment.

Treatment and study plan

Gluten-free diet

Other

Diet with gluten elimination followed by all participants for 8 weeks

Gluten capsules supplementation

Other

2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)

Placebo capsules supplementation

Other

Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).

Primary outcomes

  1. Change in gut microbiome composition

    Time frame: Baseline (T0) to week 4 (T1)

    Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.

  2. Change in gut microbiome composition

    Time frame: Week 4 (T1) to week 8 (T2)

    Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.

  3. Change in thyroid stimulating hormone (TSH)

    Time frame: Baseline (T0) to week 4 (T1)

  4. Change in thyroid stimulating hormone (TSH)

    Time frame: Week 4 (T1) to week 8 (T2)

  5. Change in thyroid hormone thyroxine (FT4)

    Time frame: Baseline (T0) to week 4 (T1)

  6. Change in thyroid hormone thyroxine (FT4)

    Time frame: Week 4 (T1) to week 8 (T2)

  7. Change in thyroid hormone triiodothyronine (FT3)

    Time frame: Baseline (T0) to week 4 (T1)

  8. Change in thyroid hormone triiodothyronine (FT3)

    Time frame: Week 4 (T1) to week 8 (T2)

  9. Change in thyroid peroxidase antibodies (TPOAb)

    Time frame: Baseline (T0) to week 4 (T1)

  10. Change in thyroid peroxidase antibodies (TPOAb)

    Time frame: Week 4 (T1) to week 8 (T2)

  11. Change in thyroglobulin antibodies (TgAb)

    Time frame: Baseline (T0) to week 4 (T1)

  12. Change in thyroglobulin antibodies (TgAb)

    Time frame: Week 4 (T1) to week 8 (T2)

  13. Change in quality of life measured in ThyPROpl questionnaire

    Time frame: Baseline (T0) to week 4 (T1)

    ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire. ThyPRO is recommended for the assessment of health-related quality of life in patients with benign thyroid disease.

    ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. Patients are asked to rate their responses for each item on a five-point Likert scale: 0 - not at all; 1 - a little; 2 - some; 3 - quite a bit; 4 - very much. Higher scores mean an improvement in the quality of life.

  14. Change in quality of life measured in ThyPROpl questionnaire

    Time frame: Week 4 (T1) to week 8 (T2)

    ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire. ThyPRO is recommended for the assessment of health-related quality of life in patients with benign thyroid disease.

    ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. Patients are asked to rate their responses for each item on a five-point Likert scale: 0 - not at all; 1 - a little; 2 - some; 3 - quite a bit; 4 - very much. Higher scores mean an improvement in the quality of life.

Secondary outcomes

  1. Change in erythrocyte sedimentation rate (ESR)

    Time frame: Baseline (T0) to week 4 (T1)

  2. Change in erythrocyte sedimentation rate (ESR)

    Time frame: Week 4 (T1) to week 8 (T2)

  3. Change in C-reactive protein (CRP)

    Time frame: Baseline (T0) to week 4 (T1)

  4. Change in C-reactive protein (CRP)

    Time frame: Week 4 (T1) to week 8 (T2)

  5. Change in fasting glucose

    Time frame: Baseline (T0) to week 4 (T1)

  6. Change in fasting glucose

    Time frame: Week 4 (T1) to week 8 (T2)

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Collaborators

  • Nutricia Foundation

Registry information

Official study title

The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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