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

Phase 2

Completed

• Conditions: Antibiotic-associated Loose/Watery Stools
• Interventions: Dietary Supplement: Probiotic capsules; Dietary Supplement: Placebo capsules

• Registration Number: NCT01940913
• Lead Sponsor: Probi AB

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 available

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Study Start: 2013-10
• Primary Completion: 2014-04
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotic capsules	-
Placebo	Placebo capsules	-

Primary Outcome Measures

Name	Time	Method
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.	19-24 days

Trial Locations

Locations (1)

Multicenter study at 13 health care centers in Warsaw; 🇵🇱 Warsaw, Poland