Effect of a Low FODMAP Diet on SIBO Breath Test Positivity
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- SIBO Diagnosis
研究概览
简要总结
Bloating is the most common symptom associated with disorders of brain-gut interaction (i.e., functional bowel disorders) such as irritable bowel syndrome, a disorder characterized by abdominal pain and altered bowel habits which affects up to 11% of world population. A common cause of bloating is small intestinal bacterial overgrowth (SIBO), a condition defined by excessive and/or abnormal type of bacteria in the small bowel. The potential role of SIBO for irritable bowel syndrome (IBS) was initially proposed by Pimentel et al. Using lactulose breath tests (LBTs), 78% of patients with IBS were also diagnosed with SIBO. After antibiotic therapy, 48% of patients no longer met the Rome criteria for IBS. A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS.
详细描述
Despite the clinical efficacy of LFD in improving symptoms of IBS-D, its mechanism of action is not clear. Recently, Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models, both of which are reversible when rats were fed an LFD. They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level. However, studies evaluating the effect of LFD on colonic permeability of humans are lacking. Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO. Thus, the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years at the time of screening
- •Meet Rome IV criteria for functional bloating
- •IBS-SSS score of at 176 (0-500)
- •SIBO positive
排除标准
- •individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- •individuals with peanut, soy, or seafood allergies or insulin-dependent diabetes
- •known history of celiac disease, inflammatory bowel disease or microscopic colitis
- •prior small bowel or colonic surgery or cholecystectomy
- •pregnant patients
- •antibiotics, excluding topical, in the past 3 months
结局指标
主要结局
SIBO Diagnosis
时间窗: four weeks
Number of Participants with Negative and Positive SIBO
次要结局
未报告次要终点
研究者
Judy Nee
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center