Efficacite et Innocuite du Tannate de Gelatine Dans le Traitement de la Diarrhee aiguë de l'Enfant. Une Etude Randomisee, Controlee, en Double Aveugle (INDIGO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Duration of diarrhea
研究概览
简要总结
To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.
详细描述
Study purpose:
To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.
Study centers/ settings: The recruitment will take place in public health facilities in Senegal.
Proposed site is the Niakhar Center IRD BP 1386 Hann Mariste, Dakar-Senegal) with the health center of Niakhar as satellite site. More sites can be opened at the discretion of the Sponsor if required
Study design and type:
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AGE defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale ≥ 6 or, the Brussels Infant and Toddler Stool Scale (BITSS) =4 in the case of infants ≤ 3 years (see Annex 1) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h),
- •AGE lasting between 1 day and 2 days;
- •Children from 3 months old
- •Children up to 14 years old;
- •Written informed consent form signed by parents or legal guardians must be provided to caregivers.
- •Subject willing and able to comply with study restrictions and willing to return to the health center and to perform the follow-up evaluation as specified in the protocol.
排除标准
- •Use of antibiotics, diosmectite, probiotics, racecadotril, loperamide or zinc (including zinc containing ORS) within a week prior to enrolment
- •Chronic diarrheal gastrointestinal disease (e.g, inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)
- •Immunodeficiencies
- •Signs of malnutrition according to the opinion of the investigator (weight/height under 3rd z score as per World Health Organization [WHO] Child Growth Standards)
- •Need for Intravenous rehydration
- •Subject who previously entered in a clinical study within the past 30 days.
- •Pregnancy and suspected Pregnancy
结局指标
主要结局
Duration of diarrhea
时间窗: 48 hours
Duration of diarrhea, defined as the time between start of diarrhea and the normalization of stool consistency according to the BSF or BITSS (in BSF scale, =3 or =4; in BITSS, =2), or/and the time until the normalization of the number of stools (compared with the period before the onset of diarrhea), and the presence of normal stools for 48 h.
次要结局
未报告次要终点