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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01940913
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Loose/Watery Stools Dietary Supplement: Probiotic capsules Dietary Supplement: Placebo capsules Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : October 2013
Primary Completion Date : April 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Probiotics Dietary Supplement: Probiotic capsules
Placebo Comparator: Placebo Dietary Supplement: Placebo capsules


Outcome Measures

Primary Outcome Measures :
  1. Reduction of the incidence of loose/watery stools following antibiotic treatment in children. [ Time Frame: 19-24 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940913


Locations
Poland
Multicenter study at 13 health care centers in Warsaw
Warsaw, Poland
Sponsors and Collaborators
Probi AB
More Information

Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT01940913     History of Changes
Other Study ID Numbers: ProAAD
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014