Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00826137
First received: December 29, 2008
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.


Condition Intervention Phase
Antibiotic-Associated Diarrhea
Dietary Supplement: Inulin and fructo-oligosaccharides.
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Prevention of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treated with prebiotics.
Dietary Supplement: Inulin and fructo-oligosaccharides.
Supplement during antibiotic treatment+14 days.
Other Name: Placebo is base powder of product with no oligosaccharides.
Placebo Comparator: B
Placebo treated.
Dietary Supplement: Placebo
Placebo is base powder of product with no oligosaccharides.

Detailed Description:

Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.

  Eligibility

Ages Eligible for Study:   6 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children with acute infection.

Exclusion Criteria:

  • Hypersensitivity to antibiotics, chronic illness.
  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: NCT00826137

Locations
Israel
Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Zvi Weizman, MD Soroka Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00826137     History of Changes
Other Study ID Numbers: Sor472908ctil
Study First Received: December 29, 2008
Last Updated: June 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
prebiotics
Antibiotic-associated diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014