Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PAF levels
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are still to be fully understood, but immune response is known to be involved. In this study, the investigators researched the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.
详细描述
The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria, whose inflammatory markers were measured at baseline and after 6 weeks of dietary intervention. The subjects were monitored in a general practice outpatient setting (GP) and nutritional advice was offered remotely via two telephone sessions with a nutritionist. The researchers investigated the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS).
Data monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy).
All data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS (according to ROME IV criteria)
- •blood analysis within 1yr with CBC, TSHr, ESR, CRP, urine, glucose
- •attitude to change dietary habits
- •willing to follow study protocol
排除标准
- •low BMI (<18.5 kg/m2)
- •pregnancy
- •restrictive dietary habits (e.g. veganism)
- •positive FOBT
- •faecal calprotectin >200 mcg/g
- •known or recurrent bowel infections
- •known or recurrent UTI (>3/yr)
- •former diverticulitis
- •alcohol abuse
- •major concurrent disease (e.g. IBD, coeliac disease, eating disorder,...)
- •pharmacological treatment with drugs that alter intestinal motility (e.g. PPI, metformin,...)
结局指标
主要结局
PAF levels
时间窗: 6 weeks
reduction of PAF levels from baseline
BAFF levels
时间窗: 6 weeks
reduction of BAFF levels from baseline
次要结局
- IBS symptom severity(6 weeks)
- BMI(6 weeks)