RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- time of resolution of diarrhea
研究概览
简要总结
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition.
There is no specific treatment, so it is exclusively symptomatic
A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions.
Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.
详细描述
A randomized, blinded study with a control group is proposed in this project to establish solidly the efficacy of xyloglucan in the treatment of acute gastroenteritis in children.
The main variable of evaluation will be the duration of diarrhea, defined as the time it takes to normalize the consistency of stools (according to the Bristol or Amsterdam scale) or their number.
Clinical trial in phase IV with medical product type IIa and CE marking, used in the same conditions in which it is marketed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h
- •Age over 3 months and under 5 years
- •Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians
排除标准
- •Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week
- •Exclusive breastfeeding
- •Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy)
- •Immunodeficiencies
- •Malnutrition (weight / height / length less than P3 according to WHO standards)
- •Severe dehydration
- •Impossibility of follow-up
- •Known hypersensitivity to gelatin or xyloglucan
- •Absence of informed consent
- •Caregivers / parents who can not understand or comply with all the instructions and requirements of the study.
- •If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could negatively influence
研究组 & 干预措施
XYLOGLUCAN
treatment regimen with oral rehydration solution and xyloglucan
干预措施: medical device (Other)
PLACEBO
rehydration solution and placebo.
干预措施: medical device (Other)
结局指标
主要结局
time of resolution of diarrhea
时间窗: 14 days
Number of days
次要结局
未报告次要终点
研究者
Enriqueta Roamn
MD
Puerta de Hierro University Hospital