Fecal Calprotectin Levels in Patients With Fibromyalgia

Completed

• Conditions: Fibromyalgia; Irritable Bowel Syndrome; Abdominal Pain
• Interventions: Diagnostic Test: Fecal calprotectin measurement

• Registration Number: NCT05404893
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Primary Completion: 2022-06-07
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibromyalgia without gastrointestinal symptoms	Fecal calprotectin measurement	Patients diagnosed as having Fibromyalgia according to american college of rheumatology 2016 classification criteria, with no abdominal pain, constipation, diarrhea, tenesmus, abdominal cramps
Fibromyalgia with gastrointestinal symptoms	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
Healthy controls	Fecal calprotectin measurement	Healthy controls, no gastrointestinal symptoms

Primary Outcome Measures

Name	Time	Method
Fecal calprotectin levels	1 day	Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 Bornova, Izmir, Turkey