The Effect of Low-FODMAP Diet on Leaky Gut ,Symptoms and Quality of Life in Patient With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- change zonulin levels in IBS patient
研究概览
简要总结
This study aimed to evaluate the effects of a Low-FODMAP diet on intestinal permeability, symptom severity, and quality of life in patients with Irritable Bowel Syndrome (IBS). Twenty-four patients diagnosed with IBS according to the Rome IV criteria were randomized to either a Low-FODMAP diet or a traditional diet for four weeks. Stool zonulin family peptides (ZFP), IBS Symptom Severity Score (IBS-SSS), and IBS Quality of Life (IBS-QOL) questionnaires were recorded at baseline and after the dietary intervention. In the Low-FODMAP group, FODMAP-containing foods were gradually reintroduced under dietitian supervision, and assessments were repeated at week 16 to evaluate long-term effects.
详细描述
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits without an identifiable organic cause. Dietary factors and increased intestinal permeability have been proposed as potential mechanisms contributing to symptom development.
The Low-FODMAP diet has been shown to improve IBS symptoms by reducing fermentable carbohydrate intake. However, its effects on intestinal barrier integrity remain unclear.
This prospective randomized single-blind study was conducted at Istanbul Medipol Mega University Hospital between December 2023 and December 2024. Patients aged 18-65 years diagnosed with IBS according to the Rome IV criteria were included. Participants were randomized to follow either a Low-FODMAP diet or a traditional diet for four weeks. Stool zonulin family peptides (ZFP) were measured as a biomarker of intestinal permeability. Symptom severity and quality of life were evaluated using validated IBS-SSS and IBS-QOL questionnaires.
After four weeks, patients in the Low-FODMAP group began a structured reintroduction phase where restricted foods were gradually reintroduced over twelve weeks. Follow-up assessments were performed at week 16 to evaluate long-term outcomes.
The study investigated whether dietary FODMAP restriction could improve intestinal barrier function in addition to reducing symptom severity and improving quality of life in patients with IBS.
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
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Age between 18 and 65 years
- •Diagnosis of Irritable Bowel Syndrome (IBS) according to Rome IV criteria
- •Patients presenting to Internal Medicine or Gastroenterology outpatient clinics
- •Ability to provide written informed consent
- •Willingness to comply with the assigned dietary intervention and follow-up schedule
- •Patients who were mostly compliant or fully compliant with the dietary protocol (≥51%)
排除标准
- •IBS-specific treatment within the last 1 month
- •Antibiotic or probiotic use within the previous 2 weeks
- •History of major abdominal surgery
- •Active malignancy
- •Heart failure
- •Renal failure
- •Autoimmune disease
- •Inflammatory bowel disease
- •Celiac disease
- •Lactose intolerance
- •Individuals currently following another dietary regimen
- •Poor adherence to diet protocol (<51%)
- •Failure to submit dietary diaries regularly
- •Need for antibiotic therapy during the intervention period
研究组 & 干预措施
low fodmap diet
Dietary Intervention,low fodmap diet
干预措施: low fodmap diet (Other)
traditional diet
traditional diet
干预措施: dietary intervention (Other)
结局指标
主要结局
change zonulin levels in IBS patient
时间窗: after started diet 4 weeks later and after modified low fodmap diet 8 weeks later check stool analyse again
We aim to investigate that lox fodmap diet has decreased stool zonulin level and improve leaky gut or not
次要结局
未报告次要终点
研究者
Esra Cokicli
Assoc.Prof.Dr.
Istanbul Medipol University Hospital