Clinical trial NCT05404893: Fecal Calprotectin Levels in Patients With Fibromyalgia
Official title: Fecal Calprotectin Levels in Patients With Fibromyalgia: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Abdominal Pain
Keywords: fecal calprotectin
fibromyalgia
irritable bowel syndrome
abdominal pain
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects diagnosed as having FMS according to American College of Rheumatology 2016 classification criteria (1). Group 3 will consist of healthy controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal calprotectin levels
timeFrame: 1 day
Secondary outcomes:
measure: Correlation of fecal calprotectin levels with fibromyalgia disease parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine
state: Izmir
Study officials:
affiliation: Ege university school of medicine
name: Ece Cinar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirsehir Ahievran University School of Medicine
name: Burcu Turkoglu Aytar, MD
role: STUDY_CHAIR
affiliation: Ege university school of medicine
name: Simin Hepguler, Prof.
role: STUDY_CHAIR
affiliation: Ege university school of medicine
name: Burcu Barutcuoglu, Ass.Prof.
role: STUDY_CHAIR
References:
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.
citation: 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.