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

Not Applicable

Completed

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT02722993
• Lead Sponsor: Probi AB

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 available

Study Timeline

• Study Start: 2016-02-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2017-05-08
• Study Completion: 2017-05-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of loose/watery stools	19-26 days