Efficacy and Safety of a Probiotic Product in Children Wi... | NCT01940913

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

NCT01940913

Sponsor

Probi AB

Status

Completed

Last Update Posted

May 9, 2014Estimated

Enrollment

400Estimated

Phase

Phase 2

Conditions

Antibiotic-associated Loose/Watery Stools

Interventions

Probiotic capsules
Placebo capsules

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

May 2014

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

Oct 2013

Primary Completion Date

Apr 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 12, 2013Estimated

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

May 8, 2014

Last Update Posted Date

May 9, 2014Estimated

Description Module

Brief Summary

To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the 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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.		19-24 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

Chronic intestinal disease.
Current immunodeficiency or immunosuppressive treatment.
Chronic or acute diarrhoeal disease.
Use of laxatives the week before inclusion in the study.
Antibiotic treatment for the last four weeks before inclusion in the study.
Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
Intake of any probiotic products for the last two weeks before inclusion in the study.
Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.

Accepts Healthy Volunteers

Not provided

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28438377	Derived	Olek A, Woynarowski M, Ahren IL, Kierkus J, Socha P, Larsson N, Onning G. Efficacy and Safety of Lactobacillus plantarum DSM 9843 (LP299V) in the Prevention of Antibiotic-Associated Gastrointestinal Symptoms in Children-Randomized, Double-Blind, Placebo-Controlled Study. J Pediatr. 2017 Jul;186:82-86. doi: 10.1016/j.jpeds.2017.03.047. Epub 2017 Apr 21.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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