Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity
研究概览
简要总结
Brief Summary :
The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :
How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.
Participants will :
Be given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.
Be required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention
详细描述
Functional Gastrointestinal Disorder (FGIDs), including irritable bowel syndrome (IBS) and functional dyspepsia (FD), are prevalent conditions that effects about 40% of world population and 21% of Malaysian population. They represent a significant health burden, impacting patients' quality of life. While the low FODMAP diet is effective in managing FGID around the western region, there is limited research done on comparing the impacts of diets with differing FODMAP content on symptom severity, quality of life, gut microbiota and gut barrier function of FGID patients in the Asian region as low FODMAP is restrictive. Therefore, conducting a randomised controlled trial is vital in measuring the effectiveness of diet with differing FODMAPs on FGID patients.
The objectives of this study are :
- To determine the effect of FODMAPs restriction on the gut microbiota abundance and diversity in FGID patients
- To determine the effect of FODMAPs restriction on gut barrier function after dietary intervention among FGID patients
- To determine the effect of FODMAPs restriction on the symptom severity, quality of life and psychological status in FGID patients
This study would be able to provide significant understanding of dietary management of FGID. Conducting this study would provide critical insights into the role of gut microbiota and gut barrier function in the pathophysiology of FGID, highlighting how dietary modulation can impact overall symptom management.
The study design involve screening and recruiting participants, followed by baseline data collection, randomisation, group allocation, and intervention with data collection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and above
- •Able to provide informed consent
- •Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists
- •Meet the ROME III- Asian criteria for FGID
- •Able to communicate in Malay or English language
排除标准
- •Pregnant or lactating women
- •History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis
- •Cancer of any kind
- •Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma
- •Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
- •Use of antibiotics in the preceding two weeks and/or in the past one month
- •Consumption of probiotics, prebiotics or fibre supplements in the past one month
- •Enteral feeding or texture modified diet patients
- •Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)
- •Shift workers (e.g. Nurse, doctors)
研究组 & 干预措施
Low FODMAP diet
Low FODMAP diet will be administered for two weeks
干预措施: Low FODMAP diet (Behavioral)
Gentle FODMAP diet
Gentle FODMAP diet will be administered for two weeks
干预措施: Gentle FODMAP diet (Behavioral)
Traditional Dietary Advice
Traditional Dietary advice will be administered for two weeks
干预措施: Traditional Dietary Advice (Behavioral)
结局指标
主要结局
Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity
时间窗: Measurement before (Day 1) and after the diet (Day 22)
16s RNA gene seqeuncing will be conducted on the stool samples at both baseline and post-intervention timelines. This test would target the microbial diversity by assessing the abdundance of key bacterial taxa.
Effect of FODMAP restrictions on Gut Barrier Function
时间窗: Measurement before (Day 1) and after the diet (Day 22)
The stool samples collected would be subjected to zonulin test and short-chain fatty acid quantification (SCFA) in order to assess gut barrier function of subjects at baseline and post-intervention timelines. Zonulin is a protein that reversibly modulates the intestinal permeability, while SCFA such as butyrate are by-products of the carbohydrate fermentation facilitated by gut microbiome that enhances the integrity of tight junction of the intestinal barrier
次要结局
- Effect of 2 week FODMAP restrictions on Symptom Severity (IBS-SSS questionnaire)(Measurement before (Day 1) and after the diet (Day 22))
- Effect of 2-week FODMAP restriction on Psychological Status(Measurement before (Day 1) and after the diet (Day 22))
- Effect of 2-week FODMAP restriction on Quality of Life(Measurement before (Day 1) and after the diet (Day 22))
- Effect of 2-week FODMAP restriction on Food Avoidance(Measurement before (Day 1) and after the diet (Day 22))
- Effect of 2 week FODMAP restrictions on Anthropometry(Measurement before (Day 1) and after the diet (Day 22))
- FODMAP Intake Before and After Intervention(Measurement before (Day 1) and after the diet (Day 22))
- Effect of 2-week FODMAP restrictions on Symptom Severity (GSRS questionnaire)(Measurement before (Day 1) and after the diet (Day 22))
研究者
Dr Shanthi Krishnasamy
Assistant Professor
Universiti Kebangsaan Malaysia Medical Centre