Efficacy of a Probiotic Product in Children With Antibiot... | NCT02722993

Studies
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders

NCT02722993

Sponsor

Probi AB

Status

Completed

Last Update Posted

Sep 26, 2018Actual

Enrollment

117Actual

Phase

Not Applicable

Conditions

Antibiotic-associated Diarrhea

Interventions

Probiotics
Placebo

Countries

Poland

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

Sep 2018

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

Feb 3, 2016Actual

Primary Completion Date

May 8, 2017Actual

Completion Date

May 8, 2017Actual

First Submitted Date

Mar 16, 2016

First Submission Date that Met QC Criteria

Mar 23, 2016

First Posted Date

Mar 30, 2016Estimated

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

Sep 24, 2018

Last Update Posted Date

Sep 26, 2018Actual

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

To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotics	Active Comparator		Dietary Supplement: Probiotics
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Dietary Supplement		Probiotics
Placebo

Measure	Description	Time Frame
Number of loose/watery stools		19-26 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children at the age of 1-11 years that have been prescribed antibiotic treatment.
Problems with loose stools during earlier antibiotic treatments.
Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion Criteria:

Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
Chronic or acute diarrheal disease.
Use of laxatives the week before inclusion in the study.
Antibiotic treatment for the last four weeks before inclusion in the study.
Intake of probiotic products for the last two weeks before inclusion in the study.
Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).
Patient requiring hospitalisation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piotr Socha, Prof.	Children's Memorial Health Institute, Warzaw, Poland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Warsaw			Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided