Efficacy of a Gluten-free Diet for the Treatment of Fibro... | NCT01881360

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

NCT01881360

Sponsor

Universidad de Granada

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

81Actual

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

Gluten-free diet
Hypocaloric diet

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jun 17, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena Pita Calandre, Responsible of the CTS-502 Investigation Team, Universidad de GranadaPrincipal Investigator

Lead Sponsor

Universidad de GranadaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gluten-free diet	Experimental		Other: Gluten-free diet
Hypocaloric diet	Active Comparator		Other: Hypocaloric diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten-free diet	Other	A diet that is free of the gluten component	Gluten-free diet

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena P. Calandre, M.D.	Universidad de Granada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Neurociencias "Federico Oloriz"		Granada	Granada	18012	Spain

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055050	Diet, Gluten-Free

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided