FibromyalgiaNCT05404893
Fecal Calprotectin Levels in Patients With Fibromyalgia
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome, Abdominal Pain
- What is being tested?
- Fecal calprotectin measurement
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine
Bornova, İzmir, 35100
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome, Abdominal Pain
- Being tested
- Fecal calprotectin measurement
- Keywords
- fecal calprotectin, fibromyalgia, irritable bowel syndrome, abdominal pain
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal calprotectin measurementDiagnostic test
Stool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Fecal calprotectin measurement | |
| 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 Receives: Diagnostic Test: Fecal calprotectin measurement | |
| Healthy controls | Healthy controls, no gastrointestinal symptoms Receives: Diagnostic Test: Fecal calprotectin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal calprotectin levels
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
Measured: 1 day
Secondary outcomes (1)
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Apr 2022
- Primary completion7 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Ece Cinar, MD, Principal investigator, Ege university school of medicineBurcu Turkoglu Aytar, MD, Study chair, Kirsehir Ahievran University School of MedicineSimin Hepguler, Prof., Study chair, Ege university school of medicineBurcu Barutcuoglu, Ass.Prof., Study chair, Ege university school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404893
- Sponsor's protocol ID
- Ege 20-10T/47
- Status last verified
- Jan 2023
- First submitted
- 31 May 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27916278Ayling RM, Kok K. Fecal Calprotectin. Adv Clin Chem. 2018;87:161-190. doi: 10.1016/bs.acc.2018.07.005. Epub 2018 Oct 1.
PubMed 30342711
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Calprotectin Levels in Patients With Fibromyalgia: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05404893
- Acronym / sponsor ID
- Ege 20-10T/47
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome, Abdominal Pain
- Keywords
- fecal calprotectin, fibromyalgia, irritable bowel syndrome, abdominal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia without gastrointestinal symptoms | – | Diagnostic Test: Fecal calprotectin measurementPatients 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 | – | Diagnostic Test: Fecal calprotectin measurementPatients 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 | – | Diagnostic Test: Fecal calprotectin measurementHealthy controls, no gastrointestinal symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal calprotectin measurementStool samples will be collected and fecal calprotectin levels will be measured using an enzymatic immunoassay kit. | Diagnostic test | Fibromyalgia with gastrointestinal symptoms, Fibromyalgia without gastrointestinal symptoms, Healthy controls |
Primary outcome
Fecal calprotectin levels
Time frame: 1 day
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
1 secondary outcome
Correlation of fecal calprotectin levels with fibromyalgia disease parameters
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 27916278Wolfe 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.
- Background: PubMed 30342711Ayling RM, Kok K. Fecal Calprotectin. Adv Clin Chem. 2018;87:161-190. doi: 10.1016/bs.acc.2018.07.005. Epub 2018 Oct 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece Cinar, MD principal investigator
Ege university school of medicine
Burcu Turkoglu Aytar, MD study chair
Kirsehir Ahievran University School of Medicine
Simin Hepguler, Prof. study chair
Ege university school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Irritable Bowel Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin levels (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.