Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis and chrOnic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (quality of life) in women suffering from endometriosis with chronic pelvic pain.
研究概览
简要总结
The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention.
The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) .
The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of endometriosis +/- chronic pelvic pain
- •No menopause (at least 1 menstrual cycle in the previous 6 months)
- •Informed consent from the patient and / or an authorized legal representative
排除标准
- •Postmenopause
- •Pregnancy
- •Hysterectomy or oophorectomy
- •Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)
- •History of kidney stones, cancer (except basal cell carcinoma) or diabetes
- •Modification in the course of the therapeutic intervention of the therapy for endometriosis
结局指标
主要结局
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (quality of life) in women suffering from endometriosis with chronic pelvic pain.
时间窗: 6 months
The outcome will be assessed with repeated measurements using the following parameters: Quality of life: measurement of physical and mental components with SF36 consisting of two components, one physical and one mental. Both fall within a range from 0 to 100 points where higher values are associated with better health
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.
时间窗: 6 months
The outcome will be assessed with repeated measurements using the following parameters: -Evaluation of chronic pelvic pain, dysmenorrhea, dyschezia and dysuria: VAS visual analogue scale, from 0 to 10 points where 10 points indicates worst pain
The primary outcome is to describe and evaluate the impact of nutritional intervention on clinical symptoms (intestinal function) in women suffering from endometriosis with chronic pelvic pain.
时间窗: 6 months
The outcome will be assessed with repeated measurements using the following parameters: Bowel Function: Knowles-Eccersley-Scott Symptom Questionnaire (KESS) (points)
次要结局
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Sexual Function(6 months)
- To describe and evaluate the impact of the nutritional intervention by describing the changes in Urinary function and bladder pain(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component about Depression(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some routine blood chemistry parameters(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in measurement of proteins(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Psychological component(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some Inflammatory markers(6 months)
- The secondary outcome will be to describe and evaluate the impact of the nutritional intervention by describing the changes in Intestinal inflammatory marker(6 months)
研究者
Cinzia Ferraris
Researcher
University of Pavia