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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01881360
First received: June 17, 2013
Last updated: June 18, 2013
Last verified: June 2013

June 17, 2013
June 18, 2013
January 2013
January 2015   (final data collection date for primary outcome measure)
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01881360 on ClinicalTrials.gov Archive Site
  • Change, between baseline and endpoint, in the Body Mass Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Brief Pain Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Beck Depression Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Short-form Health Survey [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the State-Trait Anxiety Inventory [ Time Frame: 0, 4, 8, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
  • Other: Gluten-free diet
    A diet that is free of the gluten component
  • Other: Hypocaloric diet
    A standard hypocaloric diet with a daily 1500 caloric intake.
  • Experimental: Gluten-free diet
    Intervention: Other: Gluten-free diet
  • Active Comparator: Hypocaloric diet
    Intervention: Other: Hypocaloric diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Elena P. Calandre, M.D. +34 958244033 epita@ugr.es
Contact: Mahmoud Slim, Ph. D. + 34 958244033 mslim@ugr.es
Spain
 
NCT01881360
FMS-GFD-013
No
Elena Pita Calandre, Universidad de Granada
Universidad de Granada
Not Provided
Principal Investigator: Elena P. Calandre, M.D. Universidad de Granada
Universidad de Granada
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP