Phenotyping and Treatment of Primary Health Care IBS Patients. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care.
The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments.
Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient.
200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County.
The study plan is structured as follows:
- Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life.
- The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients.
- The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients.
- Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments.
Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype.
All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants).
Significance
This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.
详细描述
Part 1
Study design:
Cross-sectional observational study.
Study population:
200 IBS patients, M/F, age 18-65 years, will be recruited under a period of 4 years from the primary health care in Region Örebro County. Patients will also be recruited from the general public using websites, social media and advertisements.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS symptom severity score of at least 175 (moderate to severe symptoms).
- •Age 18 to 65 years.
排除标准
- •Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease serology will not be included.
- •Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and other severe diseases such as cancer.
- •Current drug or alcohol abuse.
- •Inability to complete questionnaires in Swedish.
- •Current pharmacological treatment for their IBS symptoms, except for "over the counter" products such as loperamide or fiber.
- •Ongoing use of low FODMAP (Fermentable Mono-, di-, oligosaccharides, and polyols) diet. A current lactose free or gluten free diet will not be accepted. Earlier lactose or gluten free diet will be accepted after a wash-out period of at least 2 weeks.
- •Current psychological treatment.
- •Current psychological treatment.
结局指标
主要结局
Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)
时间窗: 10 weeks
Measures disease-specific symptoms in IBS patients
The IBS quality of life questionnaire (IBS-QoL)
时间窗: 10 weeks
Assessment of disease-specific quality of Life
次要结局
- Nepean Dyspepsia Index (NDI)(10 weeks)
- IBS severity scoring system (IBS-SSS)(10 weeks)
- Rome IV diagnostic questionnaire(10 weeks)
- Patient Health Questionnaire Somatic symptom severity ('somatization') module (PHQ-12)(10 weeks)
- The Neuroticism-Extraversion-Openness Five Factor Inventory-3 (NEO-FFI-3) questionnaire(10 weeks)
- Patient Health Questionnaire Depression Module (PHQ-9)(10 weeks)
- Visceral Sensitivity Index (VSI) questionnaire(10 weeks)
- The Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBSBRQ)(10 weeks)
- Bristol Stool Form Scale(10 weeks)
- Patient Health Questionnaire Anxiety module (GAD-7)(10 weeks)