Assessment of the Impact of the Low FODMAP Diet on Gastrointestinal Symptoms and Nutritional Status in People With Small Intestinal Bacterial Overgrowth (SIBO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score
研究概览
简要总结
This study aims to assess the impact of a low FODMAP diet (LFD) on gastrointestinal symptoms and nutritional status in individuals diagnosed with small intestinal bacterial overgrowth (SIBO). Participants were randomly assigned to either an intervention group or a control group following completion of antibiotic therapy. The intervention group followed a LFD, while the control group followed a normal diet, in accordance with the principles of rational nutrition. Gastrointestinal symptoms, nutritional status, and quality of life were assessed using questionnaires, dietary records, anthropometric measurements, and blood biochemical parameters.
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
- Single (Participant)
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
- •age > 18 years,
- •SIBO diagnosed by a doctor based on a hydrogen and methane breath test,
- •the use of one type of antibiotic at the same dose and for the same period of time.
排除标准
- •BMI < 18.5 kg/m2,
- •pregnancy and breastfeeding,
- •the occurrence of allergies and food intolerances,
- •previous operations on the digestive tract (except appendectomy and hemorrhoidectomy),
- •eating disorders,
- •inflammatory bowel diseases,
- •celiac disease,
- •cancer, heart, liver and lung diseases with severe course, as well as neurological or psychiatric diseases,
- •use of dietary modifications in the last 3 months,
- •use of antibiotics other than those prescribed by a doctor to treat SIBO in the last 3 months,
- •implanted stimulators (limitation of body composition measurement)
研究组 & 干预措施
Low FODMAP Diet Intervention Group
Participants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy.
干预措施: Low FODMAP Diet (Other)
Control Group
Participants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy.
干预措施: Healthy Eating Diet (Other)
结局指标
主要结局
Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score
时间窗: 12 weeks
Change in gastrointestinal symptom severity assessed using the Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ). The total score ranges from 0 to 100 points, with higher scores indicating more severe gastrointestinal symptoms. Assessments were performed at baseline and after the dietary intervention.
Nutritional status - Mini Nutritional Assessment (MNA)
时间窗: 12 weeks
Change in nutritional status assessed using the Mini Nutritional Assessment (MNA) questionnaire. The total score ranges from 0 to 30 points, with higher scores indicating better nutritional status. Assessments were performed at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum vitamin D concentration)
时间窗: 12 weeks
Change in serum vitamin D levels measured in ng/mL at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum folate concentration)
时间窗: 12 weeks
Change in serum folate levels measured in ng/mL at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Iron status parameters)
时间窗: 12 weeks
Change in serum iron concentration (µg/dL) measured at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum albumin concentration)
时间窗: 12 weeks
Change in serum albumin levels measured in g/L at baseline and after the dietary intervention.
Nutritional status - Anthropometric parameters (body weight)
时间窗: 12 weeks
Change in body weight (kg) measurements at baseline and after the dietary intervention.
Nutritional status - Anthropometric parameters (body mass index (BMI)
时间窗: 12 weeks
Change in BMI (kg/m²) at baseline and after the dietary intervention. BMI calculated from measured body weight and height (kg/m²).
Nutritional status - anthropometric parameters (body fat percentage)
时间窗: 12 weeks
Change in body fat percentage (%) at baseline and after the dietary intervention. Body fat percentage measured using bioelectrical impedance analysis (ACCUNIQ BC720).
次要结局
- Quality of life - IBS-specific (Irritable Bowel Syndrome-Quality of Life (IBS-QOL) total score)(12 weeks)
- Quality of Life - General (Short Form-36 Health Survey (SF-36) total score)(12 weeks)
研究者
dr hab. Ewa Lange, prof. SGGW
university professor
Warsaw University of Life Sciences