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. 2023 Feb 27;24(1):150.
doi: 10.1186/s12891-023-06259-3.

Investigating the association between the symptoms of women with Fibromyalgia, Digestive function, and markers of the microbiota of the Gastrointestinal Tract (The FIDGIT Study): study protocol

Sharon Erdrich  1 , Jason A Hawrelak  2 , Stephen P Myers  3   4 , Momchilo Vuyisich  5 , Joanna E Harnett  6
Affiliations

Investigating the association between the symptoms of women with Fibromyalgia, Digestive function, and markers of the microbiota of the Gastrointestinal Tract (The FIDGIT Study): study protocol

Sharon Erdrich et al. BMC Musculoskelet Disord. .

Abstract

Background: Fibromyalgia a common idiopathic condition affecting around 1.4% of adults globally. Its signature symptom is chronic widespread pain, with a constellation of somatic and psychological symptoms. Fibromyalgia is associated with significant reductions in quality of life, yet to date there is no biochemical marker for its diagnosis. Previous studies have indicated a strong association with gastrointestinal dysfunction, and more recently, alterations to the gut microbiome. No studies have examined the inter-relationship between fibromyalgia, gastrointestinal dysfunction, and the microbiome. This prospective observational case-controlled study will gather data on gastrointestinal function, dietary intake, fermentation patterns of ingested carbohydrates, and symptoms commonly associated with fibromyalgia. These will be evaluated alongside human gene expression and metatranscriptomic analysis of the oral and faecal microbiome.

Methods: Adult women aged ≥18 years diagnosed with fibromyalgia and/or meeting ACR 2016 criteria, and healthy family or age-matched controls will be recruited from the community. From consenting participants, we will collect detailed survey information and samples of blood, urine, stool, saliva, and breath.

Discussion: This is the first prospective study examining interactions between digestive function, human gene expression, and the gut microbiome together with general, and fibromyalgia-specific, symptoms experienced by New Zealand women. This exploration will allow an in-depth understanding of clinically relevant factors that are associated with fibromyalgia and will guide further research and contribute to improved management of this poorly understood condition.

Trial registration: The study was approved by the New Zealand Health and Disability Committee (HDEC) (ref: 20/CEN/197) and registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12620001337965. Written consent will be obtained after providing participants with detailed information about the procedures. Access to data will be restricted to the immediate research team, and all samples and survey data will be deidentified and coded before analysis.

Keywords: Fibromyalgia; Functional Gastrointestinal Disorders; Microbiome; Study Protocol.

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Conflict of interest statement

SE owns and operates the breath testing facility at the study site. MV is co-founder and research director of Viome Life Sciences. No other authors have any competing interests to declare.

References

    1. Inanici F, Yunus MB. History of fibromyalgia: past to present. Curr Pain Headache Rep. 2004;8(5):369–78. doi: 10.1007/s11916-996-0010-6. - DOI - PubMed
    1. Wolfe F, Clauw DJ, Fitzcharles M-A, Goldenberg DL, Häuser W, Katz RL, et al. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016;46(3):319–29. doi: 10.1016/j.semarthrit.2016.08.012. - DOI - PubMed
    1. Marques AP, Santo AdSdE, Berssaneti AA, Matsutani LA, Yuan SLK. Prevalence of fibromyalgia: Literature review update. Rev Bras Reumatol Engl Ed. 2017;57(4):356–63. doi: 10.1016/j.rbre.2017.01.005. - DOI - PubMed
    1. Skaer TL. Fibromyalgia: disease synopsis, medication cost effectiveness and economic burden. PharmacoEconomics. 2014;32(5):457–66. doi: 10.1007/s40273-014-0137-y. - DOI - PubMed
    1. Giorgi V, Sirotti S, Romano ME, Marotto D, Ablin JN, Salaffi F, et al. Fibromyalgia: one year in review. 2022. Clin Exp Rheumatol. 2022. 10.55563/clinexprheumatol/if9gk2. - PubMed

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