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Fecal Calprotectin Levels in Patients With Fibromyalgia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05404893
Enrollment
100
Registered
2022-06-03
Start date
2022-04-01
Completion date
2022-09-30
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Fibromyalgia, Irritable Bowel Syndrome

Keywords

fecal calprotectin, fibromyalgia, irritable bowel syndrome, abdominal pain

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.

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.

Interventions

DIAGNOSTIC_TESTFecal calprotectin measurement

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

Sponsors

Ege University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fecal calprotectin levels1 dayFecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive

Secondary

MeasureTime frameDescription
Correlation of fecal calprotectin levels with fibromyalgia disease parameters1 dayFecal calprotectin levels will be assessed for correlation with symptom severity scale and widespread pain index scores of american college of rheumatology 2016 classification criteria

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026