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Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025583
First Posted: December 3, 2009
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
  Purpose
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.

Condition Intervention Phase
Diarrhea Dietary Supplement: hypotonic oral rehydration solution Dietary Supplement: Hypotonic oral rehydration solution with Zn and prebiotics Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a New Hypotonic Oral Rehydration Solution Containing Zinc and Prebiotics in the Treatment of Children With Acute Diarrhea

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 130
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 1 (standard ORS)
Children with acute diarrhea receive standard hypotonic ORS.
Dietary Supplement: hypotonic oral rehydration solution
30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.
Other Name: REIDRAX
Active Comparator: Group 2 (hypotonic super-ORS)
Children with acute diarrhea receive hypotonic super-ORS containing zinc and prebiotics.
Dietary Supplement: Hypotonic oral rehydration solution with Zn and prebiotics
30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.
Other Name: PREREID

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 3-36 months old seen in the pediatrician offices presenting acute diarrhea lasting less than 48 h are considered eligible for the study

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025583


Locations
Italy
Pediatric Office
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Roberto Berni Canani, MD, PhD Department of Pediatrics, University Federico II of Naples Italy
  More Information

Responsible Party: Roberto Berni Canani, Department of Pediatrics University Federico II of Naples, Italy
ClinicalTrials.gov Identifier: NCT01025583     History of Changes
Other Study ID Numbers: 184/08
01§/2008 ( Other Grant/Funding Number: Mother and Child Health Association )
First Submitted: December 2, 2009
First Posted: December 3, 2009
Last Update Posted: January 13, 2010
Last Verified: December 2009

Keywords provided by Federico II University:
acute gastroenteritis
intestinal infection
intestinal fluid secretion
intestinal microflora
treatment of childhood acute diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions