Preventing Childhood Antibiotic-associated Diarrhea by Pr... | NCT00826137

Studies
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

NCT00826137

Sponsor

Soroka University Medical Center

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Antibiotic-Associated Diarrhea

Interventions

Inulin and fructo-oligosaccharides.
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 29, 2008

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Treated with prebiotics.	Dietary Supplement: Inulin and fructo-oligosaccharides.
B	Placebo Comparator	Placebo treated.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inulin and fructo-oligosaccharides.	Dietary Supplement	Supplement during antibiotic treatment+14 days.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of diarrhea.		During antibiotic treatment+14 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of diarrhea.		During antibiotic treatment+14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children with acute infection.

Exclusion Criteria:

Hypersensitivity to antibiotics, chronic illness.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zvi Weizman, MD	Soroka University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka Medical Center		Beersheba		84101	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D007444	Inulin
C116580	fructooligosaccharide

Ancestor Terms

ID	Term
D013213	Starch
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911

Browse Leaves

Not provided

Browse Branches

Not provided