Fecal Calprotectin Levels in Patients With Fibromyalgia

January 16, 2023 updated by: Ece Cinar, Ege University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Ege University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fibromyalgia without gastrointestinal symptoms
Patients diagnosed as having Fibromyalgia according to american college of rheumatology 2016 classification criteria, with no abdominal pain, constipation, diarrhea, tenesmus, abdominal cramps
Diagnostic test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
Fibromyalgia with gastrointestinal symptoms
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
Diagnostic test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
Healthy controls
Healthy controls, no gastrointestinal symptoms
Diagnostic test: Fecal calprotectin measurement
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal calprotectin levels
Time Frame: 1 day
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Ece Cinar, MD, Ege University School of Medicine
  • Study Chair: Burcu Turkoglu Aytar, MD, Kirsehir Ahievran University School of Medicine
  • Study Chair: Simin Hepguler, Prof., Ege University School of Medicine
  • Study Chair: Burcu Barutcuoglu, Ass.Prof., Ege University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ege 20-10T/47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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