Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
时间窗: 0, 4, 8, 12, 18 and 24 weeks
次要结局
- 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)
研究者
Elena Pita Calandre
Responsible of the CTS-502 Investigation Team
Universidad de Granada