Fecal Calprotectin Levels in Patients With Fibromyalgia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Diagnostic Test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
|
| 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 |
Diagnostic Test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
|
| Healthy controls Healthy controls, no gastrointestinal symptoms |
Diagnostic Test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
|
Outcome Measures
Primary Outcome Measures
- Fecal calprotectin levels [1 day]
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
Secondary Outcome Measures
- Correlation of fecal calprotectin levels with fibromyalgia disease parameters [1 day]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Older than 18 years of age
Exclusion Criteria:
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Presence of gastrointestinal symptoms starting after the age of 50.
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Presence of inflammatory rheumatological disorder
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Presence of organic gastrointestinal disorder
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History of fever, infective gastroenteritis, endoscopy or colonoscopy in the previous month
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Family history of inflammatory bowel disease
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Patients with alarm symptoms that required further investigation such as weight loss, nocturnal diarrhea, rectal bleeding
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Illiteracy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ege University School of Medicine | Bornova | Izmir | Turkey | 35100 |
Sponsors and Collaborators
- Ege University
Investigators
- Principal Investigator: Ece Cinar, MD, Ege university school of medicine
- Study Chair: 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 Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser 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.
- Ege 20-10T/47