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

May 8, 2014 updated by: Probi AB
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland
        • Multicenter study at 13 health care centers in Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion criteria

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

Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo capsules
Active Comparator: Probiotics
Dietary supplement: Probiotic capsules

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProAAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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