Effectiveness of a multistrain synbiotic product in children with acute viral diarrhea: a multicenter prospective randomized controlled study

ITF RESEARCH PHARMA S.L.U.0 个研究点目标入组 75 人开始时间: 2024年8月28日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. Children from both sex whose parents/guardians have given their informed consent to participate in the study
•2. Children aged 2 years or younger who visited the pediatrician in the primary or the emergency healthcare center, presenting an acute diarrhea episode lasting less than 48 hours, with a probable viral origin
•3. Children whose diarrhea will be treated only with diet and/or oral rehydration, on an outpatient basis
•4. Children for whom the pediatrician considers treatment with the dietary supplement Prodefen GG drops as an additional treatment measure

•1. Children who have presence of any disease that may cause diarrhea, different from an infection, such as inflammatory bowel disease, food allergy, lactose intolerance, etc.
•2. Immunocompromised children, children with valve implants, and/or those with a history of infectious endocarditis, due to the risk of bacteremia
•3. Children with severe dehydration or malnutrition
•4. Children with visible blood in stools
•5. Children with current pharmacological treatment for diarrhea
•6. Children who have used antibiotics and/or probiotics the previous 7 days
•7. Children allergic to milk protein (Prodefen GG drops may contain traces of milk, but do not affect those who are lactose intolerant)
•8. Children currently participating in another study
•9. Children allergic to any of the components of Prodefen GG drops

发起方

ITF RESEARCH PHARMA S.L.U.