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Completed

NCT Number: NCT05404893

Fecal Calprotectin Levels in Patients With Fibromyalgia

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal calprotectin measurement

Diagnostic Test

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

Primary outcomes

  1. Fecal calprotectin levels

    Time frame: 1 day

    Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive

Secondary outcomes

  1. Correlation of fecal calprotectin levels with fibromyalgia disease parameters

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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