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

U

University of Granada (UGR)

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Hypocaloric diet
Other: Gluten-free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01881360
FMS-GFD-013

Details and patient eligibility

About

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.

Full description

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.

Enrollment

81 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 2 patient groups

Gluten-free diet
Experimental group
Treatment:
Other: Gluten-free diet
Hypocaloric diet
Active Comparator group
Treatment:
Other: Hypocaloric diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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