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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Probi AB
ClinicalTrials.gov Identifier:
NCT01940913
First received: September 9, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Probi AB:

Primary Outcome Measures:
  • Reduction of the incidence of loose/watery stools following antibiotic treatment in children. [ Time Frame: 19-24 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics Dietary Supplement: Probiotic capsules
Placebo Comparator: Placebo Dietary Supplement: Placebo capsules

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940913

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

No publications provided

Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT01940913     History of Changes
Other Study ID Numbers: ProAAD
Study First Received: September 9, 2013
Last Updated: May 8, 2014
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Diarrhea
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014