An open-label, randomized, prospective study comparing safety and efficacy of multi-strain probiotic with single- strain probiotics or no probiotics in acute diarrhea in children 02- 12 years of age in India â?? A pilot investigator-initiated study.

CTQuest LLP0 个研究点目标入组 52 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.Patients 02 to 12 years of age treated on OPD basis for acute diarrhea (mild, moderate dehydration)
•2.3 or more liquid or watery stool in the last 24 hours
•3.Parents giving informed consent for participation. Children between 07-12 years willing to assent for the study.
•4.Parent and child is able to attend all scheduled visits and to comply with the study procedures.
•5.Subjectâ??s parent/legal guardian has access to a telephone.

•1.History of diarrhea lasting more than 48 hrs at time of consenting
•2.History of blood in stools
•3.Severe dehydration ( >10%, patient needs IV fluid)
•4.Chronic diarrhea
•5.Known hypersensitivity to any of the study probiotic
•6.Severely malnourished (grade III and IV according to IAP classification- see Table 4 below
•7.Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities)
•8.Diagnosis of immune deficiency (AIDS, other congenital
•immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.)
•9.Administration of antibiotics, probiotics or antidiarrheal 7 days before study
•10.Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
•11.Subjectâ??s parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
•12.Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
•Parents or guardians identified as employees of the Investigator or study center as well as family members (i.e. immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

发起方

CTQuest LLP