Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. The objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.

Detailed Description
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Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. This raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. Thus, the main objective of this study is to compare the efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with fibromyalgia that also experience celiac-type symptoms.

Official Title
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Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Gluten-free diet
* Other: Hypocaloric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients diagnosed with fibromyalgia according to the 1990 American College of Rheumatology diagnostic criteria. Patients who successfully complete the screening process for sufficient celiac-type symptoms Negative transglutaminase antibodies serological testing. Signed informed consent to participate Exclusion Criteria: Patients suffering from any disease that could prevent them from following any of the suggested diet protocols Current or previous history of substance abuse Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluten-free diet<br> | Other: Gluten-free diet<br>* A diet that is free of the gluten component<br>|
| Active Comparator: Hypocaloric diet<br> | Other: Hypocaloric diet<br>* A standard hypocaloric diet with a daily 1500 caloric intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change, between baseline and endpoint, in the number of experienced celiac-type symptoms |  | 0, 4, 8, 12, 18 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change, between baseline and endpoint, in the Body Mass Index |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the Brief Pain Inventory |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the Beck Depression Inventory |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the Short-form Health Survey |  | 0, 4, 8, 12, 18 and 24 weeks | 
| Change, between baseline and endpoint, in the State-Trait Anxiety Inventory |  | 0, 4, 8, 12, 18, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, celiac-type symptoms, gluten-free diet, hypocaloric diet