Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
The main objective of the study is to assess whether a dietary regimen based on the principles of the FODMAP diet, compared with the current treatment programme which does not include specific dietary recommendations, can improve pain symptoms in patients with symptomatic endometriosis and intestinal symptoms (i.e. bloating, nausea, constipation, diarrhoea and vomiting) attributable to irritable bowel syndrome, compared with a control group
详细描述
Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity, mostly, though not exclusively, in the pelvis. It is a chronic, estrogen-dependent inflammatory condition in which ectopic foci grow and proliferate under the action of estradiol, which plays a pro-inflammatory and anti-apoptotic role.
Pelvic pain represents the most typical manifestation of endometriosis. In particular, dysmenorrhea is the most frequent symptom.
In addition to typical gynecological symptoms, gastrointestinal symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) affect up to 90 percent of patients with endometriosis It has been reported how a diet low in oligosaccharides, disaccharides, monosaccharides, and fermentable polyols (FODMAP diet) is superior to other dietary treatments for the treatment of symptoms associated with irritable bowel syndrome.
Short-chain polysaccharides (FODMAPs) are found in a variety of fruits, vegetables and grains. FODMAPs are poorly absorbed in the gut, and are readily fermented by bacteria.
Their osmotic actions and gas production cause distention of the intestinal lumen inducing pain and bloating in patients with visceral hypersensitivity, with secondary effects on intestinal motility.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 45 years
- •BMI between 18.5 and 24.9,
- •Surgical, clinical or instrumental diagnosis of endometriosis
- •Presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, on estro-progestin or progestin treatment or in the absence of hormonal treatment
排除标准
- •Associated conditions that may cause pelvic pain independent of the presence of endometriosis (e.g., pelvic varices and salpingitis outcomes)
- •chronic inflammatory bowel disease (Crohn's disease or ulcerative rectocolitis).
- •patients with obstructive uropathy, subocclusive intestinal stenosis
- •complex adnexal masses or typical endometriomas greater than 5 cm in diameter.
- •women who are obese (BMI ≥ 30) or underweight (BMI < 18)
- •women on vegetarian-vegan dietary regimens,
- •women with metabolic diseases that require specific dietary indications such as in the case of diabetes and celiac disease.