Celiac DiseaseNCT05581628
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
An observational study of Celiac Disease and Fibromyalgia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease, Fibromyalgia
- What is being tested?
- Pain location inventory (PLI), Symptom Impact Questionnaire (SIQR) and Fibromyalgia Impact Questionnaire (FIQ)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2022to 28 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Statistical analysis of the demographic data of 60 patients diagnosed with celiac according to the ESPGHAN diagnostic criteria will be performed, and the frequency of comorbid diseases will be measured. The correlation between celiac disease and fibromyalgia will be determined and possible relationships between the two diseases will be investigated. The relationship between the presence and severity of fibromyalgia and celiac disease clinical types and modified marsh classification will be examined.
Who may be able to join
- Patients who agreed to participate in the study, signed the informed consent form, had the cognitive capacity to fill in the questionnaires and scales, and were followed up with a diagnosis of celiac will be included.
Who cannot join
- Patients whose celiac diagnosis is uncertain, who do not agree to participate in the study, and who do not have sufficient cognitive capacity will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif university
Istanbul
Okan Kucukakkas, +905064334436, okan4494@yahoo.com
About this study
Official title: EVALUATION OF THE FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals. Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disease characterized by chronic widespread body pain, fatigue, morning stiffness, subjective swelling, sleep disturbance, intestinal problems, multiple somatic and cognitive problems, especially in the back, neck, shoulders and hips. In terms of intestinal symptoms, very similar findings can be observed between celiac disease and fibromyalgia. For this reason, the presence of celiac disease in FMS patients has been investigated in many studies and its frequency has been found to be high. However, the frequency of FMS in patients with celiac disease is not clear, and an overlooked diagnosis of fibromyalgia may leave many symptoms untreated.
- Conditions
- Celiac Disease, Fibromyalgia
- Being tested
- Pain location inventory (PLI), Symptom Impact Questionnaire (SIQR), Fibromyalgia Impact Questionnaire (FIQ)
- Medical subject headings
- Celiac Disease, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain location inventory (PLI)Diagnostic test
PLI is obtained by questioning the pain in 28 regions in the last 7 days. Total score is between 0-28
Symptom Impact Questionnaire (SIQR)Diagnostic test
The SIQR score includes a total of 10 different evaluations in the last 7 days, including pain, energy, stiffness, sleep, depression, memory problems, anxiety, sensitivity to touch, balance problems, sensitivity to loud sounds-bright light-smells-cold. Each item is scored between 0-10 and the total score is obtained between 0-100. This total score is divided by 2 to get the SIQR score
Fibromyalgia Impact Questionnaire (FIQ)Diagnostic test
FIQ measures 10 different features, including physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. The maximum possible score of each sub-title is 10. Thus, the total maximum score is 100.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Patients Group | Patients previously diagnosed with celiac disease by the gastroenterology clinic. Receives: Diagnostic Test: Pain location inventory (PLI); Diagnostic Test: Symptom Impact Questionnaire (SIQR); Diagnostic Test: Fibromyalgia Impact Questionnaire (FIQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of fibromyalgia
The frequency of fibromyalgia in celiac patients will be determined as percent.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start28 Sep 2022
- Primary completion28 Dec 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Küçükakkas, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581628
- Sponsor's protocol ID
- Bezmialem4494
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
- ClinicalTrials.gov ID
- NCT05581628
- Acronym / sponsor ID
- Bezmialem4494
- Conditions
- Celiac Disease, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 28 Dec 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 14 Oct 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.
950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals. Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disease characterized by chronic widespread body pain, fatigue, morning stiffness, subjective swelling, sleep disturbance, intestinal problems, multiple somatic and cognitive problems, especially in the back, neck, shoulders and hips. In terms of intestinal symptoms, very similar findings can be observed between celiac disease and fibromyalgia. For this reason, the presence of celiac disease in FMS patients has been investigated in many studies and its frequency has been found to be high. However, the frequency of FMS in patients with celiac disease is not clear, and an overlooked diagnosis of fibromyalgia may leave many symptoms untreated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celiac Patients Group | – | Diagnostic Test: Pain location inventory (PLI), Diagnostic Test: Symptom Impact Questionnaire (SIQR), Diagnostic Test: Fibromyalgia Impact Questionnaire (FIQ)Patients previously diagnosed with celiac disease by the gastroenterology clinic. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Statistical analysis of the demographic data of 60 patients diagnosed with celiac according to the ESPGHAN diagnostic criteria will be performed, and the frequency of comorbid diseases will be measured. The correlation between celiac disease and fibromyalgia will be determined and possible relationships between the two diseases will be investigated. The relationship between the presence and severity of fibromyalgia and celiac disease clinical types and modified marsh classification will be examined.
Key inclusion criteria (1 listed)
- Patients who agreed to participate in the study, signed the informed consent form, had the cognitive capacity to fill in the questionnaires and scales, and were followed up with a diagnosis of celiac will be included.
Key exclusion criteria (1 listed)
- Patients whose celiac diagnosis is uncertain, who do not agree to participate in the study, and who do not have sufficient cognitive capacity will be excluded from the study.
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 |
|---|---|---|
| Pain location inventory (PLI)PLI is obtained by questioning the pain in 28 regions in the last 7 days. Total score is between 0-28 | Diagnostic test | Celiac Patients Group |
| Symptom Impact Questionnaire (SIQR)The SIQR score includes a total of 10 different evaluations in the last 7 days, including pain, energy, stiffness, sleep, depression, memory problems, anxiety, sensitivity to touch, balance problems, sensitivity to loud sounds-bright light-smells-cold. Each item is scored between 0-10 and the total score is obtained between 0-100. This total score is divided by 2 to get the SIQR score | Diagnostic test | Celiac Patients Group |
| Fibromyalgia Impact Questionnaire (FIQ)FIQ measures 10 different features, including physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. The maximum possible score of each sub-title is 10. Thus, the total maximum score is 100. | Diagnostic test | Celiac Patients Group |
Primary outcome
Frequency of fibromyalgia
Time frame: 3 months
The frequency of fibromyalgia in celiac patients will be determined as percent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
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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.
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 Celiac Disease and Fibromyalgia, run by Bezmialem Vakif 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of fibromyalgia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2022.