ISRCTN61965252已完成4 期
A randomized, double-blind, controlled trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in children (iDEA STUDY)
OVENTURE S.L.0 个研究点目标入组 100 人开始时间: 2020年4月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/33028102/ (added 12/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute gastroenteritis defined as a change in stool consistency according to the Bristol Stool Form (BSF) scale and/or an increase in the frequency of evacuations (typically =3 in 24 h) lasting more than 1 day and no longer than 3 days
- •2. Age group of children between = 3 months and = 14 years
- •3. A caregiver must provide written informed consent
排除标准
- •1. Use of antibiotics, gelatine tannate, diosmectite, other probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment
- •2. Exclusive breast feeding
- •3. Chronic diarrheal gastrointestinal disease (eg. inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)
- •4. Immunodeficiencies
- •5. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
- •6. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician
研究者
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