FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05581628
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bezmialem Vakif University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Fibromyalgia
Arms & Interventions

Arms

: Celiac Patients Group

Patients previously diagnosed with celiac disease by the gastroenterology clinic.

Interventions

Diagnostic Test: - 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: - 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: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bezmialem Vakif university, Istanbul, Turkey

Status

Recruiting

Address

Bezmialem Vakif university

Istanbul, ,

Site Contact

Okan Kucukakkas

okan4494@yahoo.com

+905064334436

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.