Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01025583
First received: December 2, 2009
Last updated: January 12, 2010
Last verified: December 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   3 Months to 36 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2009
Last Updated: January 12, 2010
Health Authority: Italy: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014