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

Primary Purpose

Antibiotic-associated Loose/Watery Stools

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

Probiotic capsules

Placebo capsules

About this trial

This is an interventional prevention trial for Antibiotic-associated Loose/Watery Stools

Eligibility Criteria

1 Year - 11 Years (Child)All Sexes

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.

Sites / Locations

Multicenter study at 13 health care centers in Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction of the incidence of loose/watery stools following antibiotic treatment in children.

Secondary Outcome Measures

Full Information

NCT ID

NCT01940913

First Posted

September 9, 2013

Last Updated

May 8, 2014

Sponsor

Probi AB

1. Study Identification

Unique Protocol Identification Number

NCT01940913

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Probi AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antibiotic-associated Loose/Watery Stools

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotics

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic capsules

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo capsules

Primary Outcome Measure Information:

Title

Reduction of the incidence of loose/watery stools following antibiotic treatment in children.

Time Frame

19-24 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

11 Years

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.

Facility Information:

Facility Name

Multicenter study at 13 health care centers in Warsaw

City

Warsaw

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

28438377

Citation

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.

Results Reference

derived

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

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