Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion).
研究概览
简要总结
The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.
During this study, the investigators will perform confocal laser endomiscroscopy (CLE) and/or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires.
详细描述
The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients with and without Brachyspira infection using advanced imaging. The investigators hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.
Visit 1: inclusion, questionnaires, blood, rectal barostat examination Visit 2: questionnaires, blood, stool, diaries (food and stool), sigmoidoscopy (without laxantives) Allergologist visit (skin prick test and interpretation blood results) Visit 3A: stool, confocal laser endomicroscopy (CLE) OR colonoscopic antigen provocation test (COLAP) Visit 3B: facultative: in a subset of individuals, both CLE and COLAP will be performed (during separate visits)
Visit 4,5 and 6 only if the CLE or COLAP was positive for (at least) 1 food item
Visit 4: questionnaires and dietician-led instruction which food item to exclude (positive food item(s) during CLE/COLAP,), exclusion for 4 weeks. If both CLE and COLAP are positive, the diet will be COLAP-based.
Visit 5: questionnaires, stool diary, instructions re-introduction food item(s) Visit 6: questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IBS diagnosis according to their treating physician (ROME IV).
- •Association between intake of food and GI symptoms.
- •Witnessed written informed consent prior to any study procedures.
- •Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements.
排除标准
- •Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and active malignant disease (not those that were in remission at least 5 years).
- •Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility.
- •Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test).
- •Clinical history of severe allergic reactions.
- •Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year.
- •Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.
- •Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study.
研究组 & 干预措施
Positive food item during CLE or COLAP
The food item(s) which were positive during CLE (fluorescein leakage and cell shedding) or COLAP (swelling).
干预措施: Elimination and re-introduction of CLE or COLAP positive food item(s) (Other)
结局指标
主要结局
IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion).
时间窗: 4 weeks after exclusion
the proportion of participants with an IBS-SSS reduction of ≥50 points, measured before (visit 4) and after (visit 5) exclusion of the CLE or COLAP positive food item(s) (= responders). IBS-SSS: higher IBS-SSS indicate more severe symptoms. Scores ranging 0-500.
次要结局
- IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (absolute)(4 weeks after reintroduction)
- GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after reintroduction(4 weeks after reintroduction)
- HAD (Hospital Anxiety and Depression scale) after reintroduction(4 weeks after reintroduction)
- PHQ12 (the Patient Health Questionnaire - 12) after reintroduction(4 weeks after reintroduction)
- GSRS-IBS (the Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome version) after exclusion(4 weeks after exclusion)
- HAD (Hospital Anxiety and Depression scale) after exclusion(4 weeks after exclusion)
- IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (absolute)(4 weeks after exclusion)
- IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after reintroduction (proportion)(4 weeks after reintroduction)
- PHQ12 (the Patient Health Questionnaire - 12) after exclusion(4 weeks after exclusion)
研究者
Magnus Simrén
professor
Sahlgrenska University Hospital