Fecal Calprotectin Levels in Patients With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Fibromyalgia Irritable Bowel Syndrome Abdominal Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Fecal calprotectin measurement

Intervention Type DIAGNOSTIC_TEST

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

Fecal calprotectin measurement

Intervention Type DIAGNOSTIC_TEST

Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.

Healthy controls

Healthy controls, no gastrointestinal symptoms

Fecal calprotectin measurement

Intervention Type DIAGNOSTIC_TEST

Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.

Interventions

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Fecal calprotectin measurement

Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes