An interventional study of Gluten-free diet and Gluten capsules supplementation in Autoimmune Thyroiditis, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care
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:
Participants:
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).
27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 19 interventional studies indexed under Thyroiditis, Autoimmune.
Browse Thyroiditis, Autoimmune studies →Medical University of Gdansk is the lead sponsor of 133 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).
Other: Gluten-free diet · Other: Gluten capsules supplementation
Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Other: Gluten-free diet · Other: Placebo capsules supplementation
Diet with gluten elimination followed by all participants for 8 weeks
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Baseline (T0) to week 4 (T1)
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid stimulating hormone (TSH)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid stimulating hormone (TSH)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone thyroxine (FT4)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone thyroxine (FT4)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroglobulin antibodies (TgAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroglobulin antibodies (TgAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire
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.
Time frame: Baseline (T0) to week 4 (T1)
Change in quality of life measured in ThyPROpl questionnaire
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.
Time frame: Week 4 (T1) to week 8 (T2)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline (T0) to week 4 (T1)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Week 4 (T1) to week 8 (T2)
Change in C-reactive protein (CRP)
Time frame: Baseline (T0) to week 4 (T1)
Change in C-reactive protein (CRP)
Time frame: Week 4 (T1) to week 8 (T2)
Change in fasting glucose
Time frame: Baseline (T0) to week 4 (T1)
Change in fasting glucose
Time frame: Week 4 (T1) to week 8 (T2)
Plan to share: No
Ran from Sep 2020 to primary completion in Nov 2021, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Gdansk →