The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- pain scores
研究概览
简要总结
This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet.
详细描述
This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet. Women choosing to adhere to a diet were extensively guided by a dietician in training. In addition, both groups are asked to complete three questionnaires over a period of six months; once every two months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Women were able to choose themselves whether to adhere to a diet, and to which diet, or to adhere to the control group.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with endometriosis, either through radiologic imaging (transvaginal ultrasound and/or MRI) or laparoscopy
- •A reported pain score of ≥ 3 (Visual Analogue Score (VAS), scale 0-10cm) in one or more of the following symptoms: dysmenorrhea, deep dyspareunia and chronic pelvic pain
排除标准
- •about to undergo an operation within six months
- •Undergone an operation in the past six weeks
- •a switch in hormonal therapy within six weeks
- •Women that were pregnant or breastfeeding
- •women diagnosed with a malignancy
- •An additional diagnosis with Coeliac Disease (CD) and/or lactose intolerance.
- •Not sufficient in the Dutch or English language.
结局指标
主要结局
pain scores
时间窗: 6 months
The primary outcome focused on pain scores (in VAS, scale 0-10cm) of the endometriosis-related symptoms dysmenorrhea, deep dyspareunia, chronic pelvic pain, dysuria, dyschezia, tiredness and bloating. Pain scores will be measured on a scale between 0 and 10, where 0 represents no pain at all and 10 the worst pain possible.
次要结局
- Gastro-Intestinal Health(6 months)
- Adhesion to dietary intervention(6 months)
- Quality of Life (QoL)(6 months)
研究者
Prof. Velja Mijatovic
Professor Doctor
Amsterdam UMC, location VUmc