Fecal Calprotectin Levels in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404893
• Other study ID #: Ege 20-10T/47
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Fibromyalgia
• Irritable Bowel Syndrome
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ayling RM, Kok K. Fecal Calprotectin. Adv Clin Chem. 2018;87:161-190. doi: 10.1016/bs.acc.2018.07.005. Epub 2018 Oct 1. — View Citation

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal calprotectin levels	Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive	1 day
Secondary	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	1 day