Autoimmune ThyroiditisNCT06249074
Gluten-free Diet in Women With Autoimmune Thyroiditis
A study testing Gluten-free diet and Gluten capsules supplementation in people with Autoimmune Thyroiditis, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- Gluten-free diet and Gluten capsules supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 sitePoland
- Study dates
- 22 Sep 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition 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:
Read more
- 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).
- Conditions
- Autoimmune Thyroiditis
- Being tested
- Gluten-free diet, Gluten capsules supplementation, Placebo capsules supplementation
- Keywords
- diet, gut microbiome, thyroid, gluten-free diet
- Medical subject headings
- Thyroiditis, Autoimmune, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietOther
Diet with gluten elimination followed by all participants for 8 weeks
Gluten capsules supplementationOther
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Placebo capsules supplementationOther
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
| Study group | Role | What they receive |
|---|---|---|
| Gluten | Experimental | Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8). Receives: Other: Gluten-free diet; Other: Gluten capsules supplementation |
| Placebo | Placebo comparator | Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8). Receives: Other: Gluten-free diet; Other: Placebo capsules supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4 (T1) to week 8 (T2)
Change in thyroid stimulating hormone (TSH)
Measured: Baseline (T0) to week 4 (T1)
Change in thyroid stimulating hormone (TSH)
Measured: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone thyroxine (FT4)
Measured: Baseline (T0) to week 4 (T1)
Change in thyroid hormone thyroxine (FT4)
Measured: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
Measured: Baseline (T0) to week 4 (T1)
Change in thyroid hormone triiodothyronine (FT3)
Measured: Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
Measured: Baseline (T0) to week 4 (T1)
Change in thyroid peroxidase antibodies (TPOAb)
Measured: Week 4 (T1) to week 8 (T2)
Change in thyroglobulin antibodies (TgAb)
Measured: Baseline (T0) to week 4 (T1)
Change in thyroglobulin antibodies (TgAb)
Measured: 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.
Measured: 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.
Measured: Week 4 (T1) to week 8 (T2)
Secondary outcomes (6)
Change in erythrocyte sedimentation rate (ESR)
Measured: Baseline (T0) to week 4 (T1)
Change in erythrocyte sedimentation rate (ESR)
Measured: Week 4 (T1) to week 8 (T2)
Change in C-reactive protein (CRP)
Measured: Baseline (T0) to week 4 (T1)
Change in C-reactive protein (CRP)
Measured: Week 4 (T1) to week 8 (T2)
Change in fasting glucose
Measured: Baseline (T0) to week 4 (T1)
Change in fasting glucose
Measured: Week 4 (T1) to week 8 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start22 Sep 2020
- Primary completion16 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants followed normocaloric gluten-free diet for 8 weeks. After first 4 weeks participants 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation
- Responsible party
- Sponsor
- Investigators
- Aleksandra Rodziewicz, MSc, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249074
- Sponsor's protocol ID
- RG 4/2020
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGrogan A, Seaman HE, Wright JW, de Vries CS. The incidence of autoimmune thyroid disease: a systematic review of the literature. Clin Endocrinol (Oxf). 2008 Nov;69(5):687-96. doi: 10.1111/j.1365-2265.2008.03338.x. Epub 2008 Jul 31.
PubMed 18673466Caturegli P, Kimura H, Rocchi R, Rose NR. Autoimmune thyroid diseases. Curr Opin Rheumatol. 2007 Jan;19(1):44-8. doi: 10.1097/BOR.0b013e3280113d1a.
PubMed 17143095McLeod DS, Cooper DS. The incidence and prevalence of thyroid autoimmunity. Endocrine. 2012 Oct;42(2):252-65. doi: 10.1007/s12020-012-9703-2. Epub 2012 May 29.
PubMed 22644837Vanderpump MP. The epidemiology of thyroid disease. Br Med Bull. 2011;99:39-51. doi: 10.1093/bmb/ldr030.
PubMed 21893493Proal AD, Albert PJ, Marshall TG. The human microbiome and autoimmunity. Curr Opin Rheumatol. 2013 Mar;25(2):234-40. doi: 10.1097/BOR.0b013e32835cedbf.
PubMed 23370376Ishaq HM, Mohammad IS, Guo H, Shahzad M, Hou YJ, Ma C, Naseem Z, Wu X, Shi P, Xu J. Molecular estimation of alteration in intestinal microbial composition in Hashimoto's thyroiditis patients. Biomed Pharmacother. 2017 Nov;95:865-874. doi: 10.1016/j.biopha.2017.08.101. Epub 2017 Sep 10.
PubMed 28903182Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PubMed 21885731De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.
PubMed 26416813Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
PubMed 30060266Poblocki J, Panka T, Szczuko M, Telesinski A, Syrenicz A. Whether a Gluten-Free Diet Should Be Recommended in Chronic Autoimmune Thyroiditis or Not?-A 12-Month Follow-Up. J Clin Med. 2021 Jul 22;10(15):3240. doi: 10.3390/jcm10153240.
PubMed 34362024Ch'ng CL, Jones MK, Kingham JG. Celiac disease and autoimmune thyroid disease. Clin Med Res. 2007 Oct;5(3):184-92. doi: 10.3121/cmr.2007.738.
PubMed 18056028Roy A, Laszkowska M, Sundstrom J, Lebwohl B, Green PH, Kampe O, Ludvigsson JF. Prevalence of Celiac Disease in Patients with Autoimmune Thyroid Disease: A Meta-Analysis. Thyroid. 2016 Jul;26(7):880-90. doi: 10.1089/thy.2016.0108.
PubMed 27256300Sanz Y. Effects of a gluten-free diet on gut microbiota and immune function in healthy adult humans. Gut Microbes. 2010 May-Jun;1(3):135-7. doi: 10.4161/gmic.1.3.11868. Epub 2010 Mar 16.
PubMed 21327021Nistal E, Caminero A, Vivas S, Ruiz de Morales JM, Saenz de Miera LE, Rodriguez-Aparicio LB, Casqueiro J. Differences in faecal bacteria populations and faecal bacteria metabolism in healthy adults and celiac disease patients. Biochimie. 2012 Aug;94(8):1724-9. doi: 10.1016/j.biochi.2012.03.025. Epub 2012 Apr 20.
PubMed 22542995Di Sabatino A, Volta U, Salvatore C, Biancheri P, Caio G, De Giorgio R, Di Stefano M, Corazza GR. Small Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1604-12.e3. doi: 10.1016/j.cgh.2015.01.029. Epub 2015 Feb 19.
PubMed 25701700
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis
- ClinicalTrials.gov ID
- NCT06249074
- Acronym / sponsor ID
- RG 4/2020
- Conditions
- Autoimmune Thyroiditis
- Keywords
- diet, gut microbiome, thyroid, gluten-free diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Nutricia Foundation
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All participants followed normocaloric gluten-free diet for 8 weeks. After first 4 weeks participants 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).
| Arm | Type | Receives |
|---|---|---|
| Gluten | Experimental | Other: Gluten-free diet, Other: Gluten capsules supplementationGluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8). |
| Placebo | Placebo comparator | Other: Gluten-free diet, Other: Placebo capsules supplementationPlacebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-free dietDiet with gluten elimination followed by all participants for 8 weeks | Other | Gluten, Placebo |
| Gluten capsules supplementation2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8) | Other | Gluten |
| Placebo capsules supplementationRice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8). | Other | Placebo |
Primary outcome
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.
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.
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
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.
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.
6 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Results publication: PubMed 18673466McGrogan A, Seaman HE, Wright JW, de Vries CS. The incidence of autoimmune thyroid disease: a systematic review of the literature. Clin Endocrinol (Oxf). 2008 Nov;69(5):687-96. doi: 10.1111/j.1365-2265.2008.03338.x. Epub 2008 Jul 31.
- Results publication: PubMed 17143095Caturegli P, Kimura H, Rocchi R, Rose NR. Autoimmune thyroid diseases. Curr Opin Rheumatol. 2007 Jan;19(1):44-8. doi: 10.1097/BOR.0b013e3280113d1a.
- Results publication: PubMed 22644837McLeod DS, Cooper DS. The incidence and prevalence of thyroid autoimmunity. Endocrine. 2012 Oct;42(2):252-65. doi: 10.1007/s12020-012-9703-2. Epub 2012 May 29.
- Results publication: PubMed 21893493Vanderpump MP. The epidemiology of thyroid disease. Br Med Bull. 2011;99:39-51. doi: 10.1093/bmb/ldr030.
- Results publication: PubMed 23370376Proal AD, Albert PJ, Marshall TG. The human microbiome and autoimmunity. Curr Opin Rheumatol. 2013 Mar;25(2):234-40. doi: 10.1097/BOR.0b013e32835cedbf.
- Results publication: PubMed 28903182Ishaq HM, Mohammad IS, Guo H, Shahzad M, Hou YJ, Ma C, Naseem Z, Wu X, Shi P, Xu J. Molecular estimation of alteration in intestinal microbial composition in Hashimoto's thyroiditis patients. Biomed Pharmacother. 2017 Nov;95:865-874. doi: 10.1016/j.biopha.2017.08.101. Epub 2017 Sep 10.
- Results publication: PubMed 21885731Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
- Results publication: PubMed 26416813De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.
- Results publication: PubMed 30060266Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
- Results publication: PubMed 34362024Poblocki J, Panka T, Szczuko M, Telesinski A, Syrenicz A. Whether a Gluten-Free Diet Should Be Recommended in Chronic Autoimmune Thyroiditis or Not?-A 12-Month Follow-Up. J Clin Med. 2021 Jul 22;10(15):3240. doi: 10.3390/jcm10153240.
- Results publication: PubMed 18056028Ch'ng CL, Jones MK, Kingham JG. Celiac disease and autoimmune thyroid disease. Clin Med Res. 2007 Oct;5(3):184-92. doi: 10.3121/cmr.2007.738.
- Results publication: PubMed 27256300Roy A, Laszkowska M, Sundstrom J, Lebwohl B, Green PH, Kampe O, Ludvigsson JF. Prevalence of Celiac Disease in Patients with Autoimmune Thyroid Disease: A Meta-Analysis. Thyroid. 2016 Jul;26(7):880-90. doi: 10.1089/thy.2016.0108.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Rodziewicz, MSc principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free diet and Gluten capsules supplementation in people with Autoimmune Thyroiditis, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition (time frame: Baseline (T0) to week 4 (T1)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249074, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.