Washed Microbiota Transplantation for Food Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change of weight and height
研究概览
简要总结
Food intolerance (FI) is an adverse reaction to food caused by non-immune mechanisms, mainly related to digestive enzyme deficiencies (e.g. lactase deficiency), metabolic abnormalities (e.g. impaired absorption of fructose) or toxicity of food components (e.g. histamine). Unlike immune-mediated food allergy, FI symptoms are usually delayed (hours to days after ingestion) and mild, but are difficult to diagnose and manage clinically due to the complexity and variety of mechanisms that affect approximately 20% of the world's population.
详细描述
The gut microbiota of food intolerance (FI) is different. The widespread use of artificial sweeteners (e.g. saccharin) can induce metabolic disorders by altering the structure of the intestinal flora, e.g. animal experiments have shown that the abundance of pathogenic bacteria (e.g. Bacteroides vulgatus) in the intestinal tract of mice ingesting saccharin was significantly increased, whereas the abundance of Akkermansia muciniphila was decreased, which led to impaired glucose tolerance and abnormal fat absorption, and ultimately increased the risk of obesity and diabetes mellitus. ultimately increasing the risk of obesity and diabetes . In addition, sorbitol, as a low-calorie sugar alcohol, can trigger osmotic diarrhoea when ingested in excess, while antibiotics combined with a high-fat diet further disrupts intestinal flora balance (e.g., Clostridia depletion), decreases flora sorbitol dehydrogenase activity, and leads to persistent sorbitol metabolism disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Food intolerance occurs through laboratory examination of at least two main foods
- •Underwent washed microbiota transplantation.
排除标准
- •Expected survival time <3 months;
- •Women who are pregnant or breastfeeding;
- •Other patients deemed not suitable for enrollment by the investigator.
结局指标
主要结局
change of weight and height
时间窗: baseline, 4 weeks, 12 weeks post transplantation
Weight and height will be combined to report BMI in kg/m\^2.
change of the Gastrointestinal Symptom Rating Scale(GSRS)
时间窗: baseline, 4 weeks, 12 weeks post transplantation
GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition.
次要结局
- change of insulin-like growth factor I(IGF-I),intestinal barrier function and immunoglobulin(baseline, 12 weeks post transplantation)
- the difference of the gut microbiota composition before and after washed microbiota transplantation(baseline, 12 weeks post transplantation)
- the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(12 weeks post transplantation)
研究者
Faming Zhang
Professsor, Gastroenterology
The Second Hospital of Nanjing Medical University