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| Name | Class |
|---|---|
| Nutricia Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Placebo Comparator | Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten-free diet | Other | Diet with gluten elimination followed by all participants for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 4 (T1) to week 8 (T2) |
| Change in thyroid stimulating hormone (TSH) | Baseline (T0) to week 4 (T1) | |
| Change in thyroid stimulating hormone (TSH) | Week 4 (T1) to week 8 (T2) | |
| Change in thyroid hormone thyroxine (FT4) | Baseline (T0) to week 4 (T1) | |
| Change in thyroid hormone thyroxine (FT4) | Week 4 (T1) to week 8 (T2) | |
| Change in thyroid hormone triiodothyronine (FT3) | Baseline (T0) to week 4 (T1) | |
| Change in thyroid hormone triiodothyronine (FT3) | Week 4 (T1) to week 8 (T2) | |
| Change in thyroid peroxidase antibodies (TPOAb) | Baseline (T0) to week 4 (T1) | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in erythrocyte sedimentation rate (ESR) | Baseline (T0) to week 4 (T1) | |
| Change in erythrocyte sedimentation rate (ESR) | Week 4 (T1) to week 8 (T2) | |
| Change in C-reactive protein (CRP) |
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Inclusion Criteria:
Exclusion Criteria:
Only women were included in the study because they are much more likely to suffer from autoimmune thyroiditis and to ensure more uniform results in the selected age group.
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Rodziewicz, MSc | Medical University of Gdansk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdańsk | Gdansk | 80-210 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18673466 | Result | 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. | |
| 17143095 | Result | Caturegli P, Kimura H, Rocchi R, Rose NR. Autoimmune thyroid diseases. Curr Opin Rheumatol. 2007 Jan;19(1):44-8. doi: 10.1097/BOR.0b013e3280113d1a. |
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| ID | Term |
|---|---|
| D013967 | Thyroiditis, Autoimmune |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D013966 | Thyroiditis |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| D005983 | Glutens |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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).
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| 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). |
|
| Change in thyroid peroxidase antibodies (TPOAb) |
| Week 4 (T1) to week 8 (T2) |
| Change in thyroglobulin antibodies (TgAb) | Baseline (T0) to week 4 (T1) |
| Change in thyroglobulin antibodies (TgAb) | 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. | 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. | Week 4 (T1) to week 8 (T2) |
| Baseline (T0) to week 4 (T1) |
| Change in C-reactive protein (CRP) | Week 4 (T1) to week 8 (T2) |
| Change in fasting glucose | Baseline (T0) to week 4 (T1) |
| Change in fasting glucose | Week 4 (T1) to week 8 (T2) |
| 22644837 | Result | McLeod 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. |
| 21893493 | Result | Vanderpump MP. The epidemiology of thyroid disease. Br Med Bull. 2011;99:39-51. doi: 10.1093/bmb/ldr030. |
| 23370376 | Result | Proal AD, Albert PJ, Marshall TG. The human microbiome and autoimmunity. Curr Opin Rheumatol. 2013 Mar;25(2):234-40. doi: 10.1097/BOR.0b013e32835cedbf. |
| 28903182 | Result | Ishaq 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. |
| 21885731 | Result | Wu 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. |
| 26416813 | Result | De 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. |
| 30060266 | Result | Krysiak 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. |
| 34362024 | Result | Poblocki 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. |
| 18056028 | Result | Ch'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. |
| 27256300 | Result | Roy 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. |
| 21327021 | Result | Sanz 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. |
| 22542995 | Result | Nistal 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. |
| 25701700 | Result | Di 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. |
| 17183309 | Result | Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a. |
| 33482041 | Result | El-Zawawy HT, Ahmed SM, El-Attar EA, Ahmed AA, Roshdy YS, Header DA. Study of gut microbiome in Egyptian patients with autoimmune thyroid diseases. Int J Clin Pract. 2021 May;75(5):e14038. doi: 10.1111/ijcp.14038. Epub 2021 Feb 4. |
| 33746942 | Result | Cayres LCF, de Salis LVV, Rodrigues GSP, Lengert AVH, Biondi APC, Sargentini LDB, Brisotti JL, Gomes E, de Oliveira GLV. Detection of Alterations in the Gut Microbiota and Intestinal Permeability in Patients With Hashimoto Thyroiditis. Front Immunol. 2021 Mar 5;12:579140. doi: 10.3389/fimmu.2021.579140. eCollection 2021. |
| 29320965 | Result | Zhao F, Feng J, Li J, Zhao L, Liu Y, Chen H, Jin Y, Zhu B, Wei Y. Alterations of the Gut Microbiota in Hashimoto's Thyroiditis Patients. Thyroid. 2018 Feb;28(2):175-186. doi: 10.1089/thy.2017.0395. Epub 2018 Feb 1. |
| 35140703 | Result | Xu Q, Ni JJ, Han BX, Yan SS, Wei XT, Feng GJ, Zhang H, Zhang L, Li B, Pei YF. Causal Relationship Between Gut Microbiota and Autoimmune Diseases: A Two-Sample Mendelian Randomization Study. Front Immunol. 2022 Jan 24;12:746998. doi: 10.3389/fimmu.2021.746998. eCollection 2021. |
| 27102333 | Result | Bonder MJ, Tigchelaar EF, Cai X, Trynka G, Cenit MC, Hrdlickova B, Zhong H, Vatanen T, Gevers D, Wijmenga C, Wang Y, Zhernakova A. The influence of a short-term gluten-free diet on the human gut microbiome. Genome Med. 2016 Apr 21;8(1):45. doi: 10.1186/s13073-016-0295-y. |
| 19445821 | Result | De Palma G, Nadal I, Collado MC, Sanz Y. Effects of a gluten-free diet on gut microbiota and immune function in healthy adult human subjects. Br J Nutr. 2009 Oct;102(8):1154-60. doi: 10.1017/S0007114509371767. Epub 2009 May 18. |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |
| D005502 | Food |
| D019602 | Food and Beverages |