Clinical Trial: Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of a New Hypotonic Oral Rehydration Solution Containing Zinc and Prebiotics in the Treatment of Children With Acute Diarrhea

Brief Summary: Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about their effect are scanty, especially for children living in developed countries. The investigators aim to evaluate the efficacy of a new hypotonic ORS containing zinc and prebiotics in children with acute diarrhea.

Detailed Summary:

Study Design and Funding Prospective, randomized controlled trial in collaboration with family pediatricians, who care for children up to 14 years of age in the Italian Public Health System. The study protocol was illustrated and discussed during 3 meetings. The research is not funded by any pharmaceutical company and all the authors declared no conflict of interest. The study protocol was reviewed and approved by the Ethics Committee of the University Federico II of Naples.

Participants Children 3-36 months old seen in the pediatrician offices from November 2007 to March 2008 presenting acute diarrhea lasting less than 48 h are considered eligible for the study. Exclusion criteria are: diarrhea lasting more than 48 h, malnutrition as judged by a body weight/height ratio below the 5th percentile, clinical signs of severe dehydration, clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic disease, malnutrition, cystic fibrosis, food allergy or other chronic gastrointestinal diseases, use of pre/probiotics in the previous 3 weeks, use of antibiotics or any antidiarrheal medication in the previous 3 weeks.

Acute diarrhea is defined as a decrease in the consistency of stools (loose or liquid) and/or an increase of frequency of evacuations (3 or >3 in 24 h), with or without fever or vomiting. Informed consent is obtained from the parents of all enrolled children. Microbiologic and other laboratory investigations performed only if required for specific clinical reasons.

Intervention Enrolled patients are randomly allocated to standard hypotonic ORS (group 1) or to super-hypotonic ORS containing zinc and prebiotics (group 2). We used two commercial ORS ORS preparations available on the market as
Sponsor: Federico II University

Current Primary Outcome: The primary outcome of the study is the rate of resolution of diarrhea 72 h after starting oral rehydration therapy. [ Time Frame: From November 2007 to January 2008 ]

Original Primary Outcome: The primary outcome of the study is the rate of resolution of diarrhea 72 h after starting oral rehydration therapy.

Current Secondary Outcome: Secondary outcome measures are the total amount of ORS intake in the first 24 h, the number of missed work days of the parent, the number of hospital admissions in each group, and the use of other medications. [ Time Frame: From November 2007 to January 2008 ]

Original Secondary Outcome: Secondary outcome measures are the total amount of ORS intake in the first 24 h, the number of missed work days of the parent, the number of hospital admissions in each group, and the use of other medications.

Information By: Federico II University

Dates:
Date Received: December 2, 2009
Date Started: November 2007
Date Completion:
Last Updated: January 12, 2010
Last Verified: December 2009