a randomised controlled trial on the effect of oral rehydration solution (ORS) and a new symbiotic formulation called FLORTEC versus oral rehydration solution (ORS) on duration of diarrhea in children with acute gastroenteritis

Department of Pediatrics University of Naples Federico II0 个研究点目标入组 90 人开始时间: 2011年6月23日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Children aged between 3 and 36 months with acute gastroenteritis defined as increase in the number of bowel movements (> 3 / 24 h) and / or changes in stool consistency referred to family pediatrician's ambulatories; Onset of symptoms <48 hours prior to enrollment. Evidence of mild to moderate dehydration (loss of 3-9% of body weight) to the clinical evaluation: weight loss, depression anterior fontanel, hollows of eyeballs, dryness of mucous membranes, loss of skin elasticity, lowering of respiratory rate, arterial pulse, blood pressure, body temperature, urination, lachrymation

•Dystrophy (weight/lenght<5 centile), duration of diarrhea > 48 hours, food allergies/ intolerances, assumption of substances that alter the intestinal microflora (probiotics, prebiotics and antibiotics) or have adsorption properties (diosmectite) or modify the intestinal secretion (racecadotril, loperamide), Chronic bowel diseases (celiac disease, inflammatory bowel diseases, cystic fibrosis or other forms of primitive pancreatic insufficiency), gastrointestinal malformations(intestinal atresia, short bowel syndrome, etc.), primary or secondary immunodeficiencies, systemic infections

发起方

Department of Pediatrics University of Naples Federico II