An observational study in Fibromyalgia, Irritable Bowel Syndrome and Abdominal Pain, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Ege University · Observational
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.
1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult subjects diagnosed as having FMS according to American College of Rheumatology 2016 classification criteria (1). Group 3 will consist of healthy controls
Exclusion Criteria:
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
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
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.
Fecal calprotectin levels
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
Time frame: 1 day
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
Time frame: 1 day
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ege University