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

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

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-03

Study Completion Date

2017-05-08

Brief Summary

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

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Detailed Description

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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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Probiotics

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No