Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

NCT ID: NCT00826137

Last Updated: 2012-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Antibiotic-Associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Treated with prebiotics.

Group Type EXPERIMENTAL

Inulin and fructo-oligosaccharides.

Intervention Type DIETARY_SUPPLEMENT

Supplement during antibiotic treatment+14 days.

B

Placebo treated.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo is base powder of product with no oligosaccharides.

Interventions

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Inulin and fructo-oligosaccharides.

Supplement during antibiotic treatment+14 days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo is base powder of product with no oligosaccharides.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo is base powder of product with no oligosaccharides.

Eligibility Criteria

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Inclusion Criteria

* Healthy children with acute infection.

Exclusion Criteria

* Hypersensitivity to antibiotics, chronic illness.
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zvi Weizman, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Sor472908ctil

Identifier Type: -

Identifier Source: org_study_id

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