Gluten-free Diet in Women With Autoimmune Thyroiditis

Autoimmune Thyroiditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249074
• Other study ID #: RG 4/2020
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2024
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 30, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Hashimoto Disease
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Other:
• Gluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
• Gluten capsules supplementation
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
• Placebo capsules supplementation
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Gdansk	Nutricia Foundation

Country where clinical trial is conducted

Poland, 

References & Publications (22)

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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 benef — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):17 — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Change in thyroid stimulating hormone (TSH)		Baseline (T0) to week 4 (T1)
Primary	Change in thyroid stimulating hormone (TSH)		Week 4 (T1) to week 8 (T2)
Primary	Change in thyroid hormone thyroxine (FT4)		Baseline (T0) to week 4 (T1)
Primary	Change in thyroid hormone thyroxine (FT4)		Week 4 (T1) to week 8 (T2)
Primary	Change in thyroid hormone triiodothyronine (FT3)		Baseline (T0) to week 4 (T1)
Primary	Change in thyroid hormone triiodothyronine (FT3)		Week 4 (T1) to week 8 (T2)
Primary	Change in thyroid peroxidase antibodies (TPOAb)		Baseline (T0) to week 4 (T1)
Primary	Change in thyroid peroxidase antibodies (TPOAb)		Week 4 (T1) to week 8 (T2)
Primary	Change in thyroglobulin antibodies (TgAb)		Baseline (T0) to week 4 (T1)
Primary	Change in thyroglobulin antibodies (TgAb)		Week 4 (T1) to week 8 (T2)
Primary	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)
Primary	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)
Secondary	Change in erythrocyte sedimentation rate (ESR)		Baseline (T0) to week 4 (T1)
Secondary	Change in erythrocyte sedimentation rate (ESR)		Week 4 (T1) to week 8 (T2)
Secondary	Change in C-reactive protein (CRP)		Baseline (T0) to week 4 (T1)
Secondary	Change in C-reactive protein (CRP)		Week 4 (T1) to week 8 (T2)
Secondary	Change in fasting glucose		Baseline (T0) to week 4 (T1)
Secondary	Change in fasting glucose		Week 4 (T1) to week 8 (T2)