Clinical trial NCT03129906: Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
Official title: Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia; non-celiac gluten sensitivity
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants received placebo capsules and, after that, gluten capsules.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to evaluate the presence of NCGS in the beginning, 8th week and 10 week.

Detailed description: Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. Recent studies point to the possibility of gluten protein having a role in the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. Questionnaires will be carried out to evaluate the quantity and severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of NCGS.

Eligibility criteria: Inclusion Criteria:

• Women between 18 and 65 years of age with prior clinical diagnosis of FM, according to the American College of Rheumatology criteria of 2010

Exclusion Criteria:

* Subjects diagnosed with positive serology for celiac disease or allergy to wheat
* Subjects diagnosed with autoimmune diseases
* Subjects with diseases that are not part of the comorbidities associated with FM and t hat could influence the results of the study
* Pregnant or lactating women

Primary outcomes:
measure: Changes in fibromyalgia Symptoms by Salerno protocol
timeFrame: Baseline, 4th and 8th weeks, 10th week
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline, 8th and 10th weeks
measure: Height
timeFrame: baseline
measure: changes in BMI
timeFrame: Baseline, 8th and 10th weeks
measure: Changes in IL-6 blood concentration
timeFrame: Baseline, 8th and 10th weeks
measure: Changes in IL-10 blood concentration
timeFrame: Baseline, 8th and 10th weeks
measure: Changes in IL-1beta blood concentration
timeFrame: Baseline, 8th and 10th weeks
measure: changes in Food intake
timeFrame: Baseline, 8th and 10th weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Laboratório de Aterosclerose e Bioquimica Nutricional
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Jacqueline I Alvarez-Leite, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: