Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed
研究概览
简要总结
Many patients with endometriosis experience extra genital and abdominal symptoms as a major part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal structure and function elicited by the endometriotic elements, which may cause a "visceral syndrome" with the above mentioned symptoms.
The investigators hypothesize that dietary treatment will improve the experience of gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study investigating patients with both endometriosis and IBS, is to test the application of a low FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot study is to investigate the applicability of a placebo diet in patients with endometriosis and to investigate the compliance in both intervention group and control group. In addition, the aim is to investigate whether the participants find the diet manageable and whether they are able to identify the placebo diet.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age 18-50 years
- •Fluid spoken and written Danish
- •Diagnosed endometriosis (laparoscopy and/or MR-scan) at least one year ago and sufficient treated regarding medicine and surgery. Participant will be asked to bring a copy of their medical record from the hospital or from www.sundhed.dk to verify the diagnosis.
- •Diagnosis of irritable bowel syndrome according to the Rome III criteria. Both previous diagnosis and undiagnosed patients are included, as long as the study group evaluates that the patient meets the Rome III criteria.
- •Accept to follow a controlled exclusion diet for all meals for four weeks with only few accepted deviations from the diet.
排除标准
- •Premature menopause
- •Organic bowel disease (Celiac disease, IBD, bowel endometriosis, malignant disease)
- •New therapeutic interventions during study period (medical/lifestyle/psychological). Already ongoing treatment is accepted.
- •Psychiatric disorder, psychotropic drugs
- •Patients, who the dietician accesses are familiar with low FODMAP diet and therefore is able to identify the placebo diet
- •Patients with complicated dietary needs, e.g. severe allergies or intolerances (including lactose and fructose intolerance), athletes, any type of vegetarianism or metabolic diseases
- •Pregnancy or planned pregnancy during the study period
研究组 & 干预措施
Low FODMAP diet
This group will follow a exclusion diet called low FODMAP diet, which is a diet with restriction of fermentable carbohydrates. The patients will be guided on how to avoid some foods and how to include others. The patients will follow the diet for four weeks.
干预措施: Diet low in fermentable carbohydrates (low FODMAP diet) (Other)
Control diet
This group will follow a placebo diet, which is designed to imitate the low FODMAP diet by restricting specific foods. However, it is randomly selected foods that will be excluded in this diet, so that it works only as a control diet. The patients in this group will also be guided how to follow the diet for four weeks.
干预措施: Diet low in fermentable carbohydrates (low FODMAP diet) (Other)
结局指标
主要结局
Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed
时间窗: four weeks
How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group
时间窗: four weeks
Identification of intervention group measured by the question: "What group do you think you were assigned to?"
时间窗: four weeks
次要结局
- Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version(four weeks)
- IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life(four weeks)
- Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)(four weeks)
- Intake of nutrients calculated in by: The Monash University Comprehensive Food Frequency Questionnaire (CNAQ) based on the participants self-reported 7-days food registration(four weeks)
- Intermenstrual pain measured by VAS scale(four weeks)
- Global symptom relief measured by the question: "Did you have sufficient relief in your IBS-symptoms during the last 7 days?"(four weeks)