A Multicentric, Randomized, Double Blind, Placebo Controlled Trial to assess the Efficacy and Safety of Saccharomyces Boulardii CNCM-I 3799 Bacillus Subtilis CU â?? 1 combination For treatment of Acute Diarrhoea in Indian Children

Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects aged between 6 months - 5 years of either gender presenting with acute diarrhea of <= 72 hours duration without history of intake of any antibiotic and without dehydration or with features of mild or moderate dehydration.
•2.Parent or legal guardian of the subjects /subject must give written informed consent for study participation.
•3.Parent of the subjects must follow all instructions as per the protocol

•1.Subjects with clinical signs of dysentery, severe dehydration requiring hospitalization or parenteral fluid therapy.
•2.Intake of any systemic antibiotic or any anti-diarrheal medication, in the previous 3 weeks prior to screening
•3.Subjects who are debilitated or seriously ill or immunocompromised.
•4.Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohnâ??s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation.
•5.Use of probiotics in the last 3 weeks prior to baseline visit.
•6.Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
•7.Subjects who have undergone ileostomy, jejunostomy or colostomy
•8.Subjects with hypersensitivity to any ingredient in the formulation.
•9.Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc.

发起方

Alkem Laboratories Limited