Preventing Childhood Antibiotic-Associated Diarrhea by Prebiotics - Full Text View

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00826137

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 III

MedlinePlus related topics: Antibiotics Diarrhea Dietary Supplements Diets

Drug Information available for: Fructooligosaccharides Inulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prebiotics in the Prevention of Antibiotic-Associated Diarrhea in Children

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 ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Treated with prebiotics.	Dietary Supplement: Inulin and fructo-oligosaccharides. Supplement during antibiotic treatment+14 days.
B: Placebo Comparator 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

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 Medical Center ( Zvi Weizman, MD )
Study ID Numbers:	Sor472908ctil
Study First Received:	December 29, 2008
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00826137 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:

prebiotics
Antibiotic-associated diarrhea

Study placed in the following topic categories:

Anti-Bacterial Agents
Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Signs and Symptoms
Diarrhea

Signs and Symptoms, Digestive
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009