Fecal Calprotectin Levels in Patients With Fibromyalgia

Study Overview
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Brief Summary
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This study was designed to evaluate fecal calprotectin levels in patients with fibromyalgia syndrome. Fecal calprotectin levels from fibromyalgia patients with and without gastrointestinal symptoms as well as healthy controls will be measured and compared.

Detailed Description
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Fecal calprotectin (FC) is a calcium and zinc binding protein that is present in neutrophil granulocytes and is detected in the stool samples from subjects with inflammatory bowel disease and similar organic gastrointestinal pathologies. Fibromyalgia is often accompanied by irritable bowel syndrome, which is a non-inflammatory, functional disorder of the gastrointestinal tract. Due to the chronic nature of the disease, fibromyalgia patients' new symptoms related to underlying gastrointestinal organic disease may be overlooked. In this study we aimed to assess the FC levels in fibromyalgia patients and healthy controls in order to detect a possible difference in FC levels between patients with and without gastrointestinal symptoms.

Official Title
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Fecal Calprotectin Levels in Patients With Fibromyalgia: A Cross-sectional Study

Conditions
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Fibromyalgia, Irritable Bowel Syndrome, Abdominal Pain

Intervention / Treatment
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* Diagnostic Test: Fecal calprotectin measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Groups 1 and 2: patients diagnosed as having Fibromyalgia syndrome according to American College of Rheumatology 2016 classification criteria (8). Group 3 will consist of healthy controls Older than 18 years of age Exclusion Criteria: Presence of gastrointestinal symptoms starting after the age of 50. Presence of inflammatory rheumatological disorder Presence of organic gastrointestinal disorder History of fever, infective gastroenteritis, endoscopy or colonoscopy in the previous month Family history of inflammatory bowel disease Patients with alarm symptoms that required further investigation such as weight loss, nocturnal diarrhea, rectal bleeding Illiteracy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromyalgia without gastrointestinal symptoms<br>Patients diagnosed as having Fibromyalgia according to american college of rheumatology 2016 classification criteria, with no abdominal pain, constipation, diarrhea, tenesmus, abdominal cramps | Diagnostic Test: Fecal calprotectin measurement<br>* Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.<br>|
| Fibromyalgia with gastrointestinal symptoms<br>Patients diagnosed as having Fibromyalgia according to american college of rheumatology 2016 classification criteria, with abdominal pain and constipation and/or diarrhea and/or tenesmus and/or abdominal cramps | Diagnostic Test: Fecal calprotectin measurement<br>* Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.<br>|
| Healthy controls<br>Healthy controls, no gastrointestinal symptoms | Diagnostic Test: Fecal calprotectin measurement<br>* Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal calprotectin levels | Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of fecal calprotectin levels with fibromyalgia disease parameters | Fecal calprotectin levels will be assessed for correlation with symptom severity scale and widespread pain index scores of american college of rheumatology 2016 classification criteria | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal calprotectin, fibromyalgia, irritable bowel syndrome, abdominal pain