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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia without gastrointestinal symptoms | Patients diagnosed as having Fibromyalgia according to american college of rheumatology 2016 classification criteria, with no abdominal pain, constipation, diarrhea, tenesmus, abdominal cramps |
| |
| Fibromyalgia with gastrointestinal symptoms | 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 |
| |
| Healthy controls | Healthy controls, no gastrointestinal symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal calprotectin measurement | Diagnostic Test | Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal calprotectin levels | Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive | 1 day |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects diagnosed as having FMS according to American College of Rheumatology 2016 classification criteria (1). Group 3 will consist of healthy controls
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| Name | Affiliation | Role |
|---|---|---|
| Ece Cinar, MD | Ege university school of medicine | Principal Investigator |
| Burcu Turkoglu Aytar, MD | Kirsehir Ahievran University School of Medicine | Study Chair |
| Simin Hepguler, Prof. | Ege university school of medicine | Study Chair |
| Burcu Barutcuoglu, Ass.Prof. | Ege university school of medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University School of Medicine | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27916278 | Background | Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. | |
| 30342711 | Background | Ayling RM, Kok K. Fecal Calprotectin. Adv Clin Chem. 2018;87:161-190. doi: 10.1016/bs.acc.2018.07.005. Epub 2018 Oct 1. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Stool samples
| D009422 |
| Nervous System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |