Back to resultsEfficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
Primary Purpose
Antibiotic-associated Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic-associated Diarrhea
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotics
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of loose/watery stools
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02722993
Brief Title
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of loose/watery stools
Time Frame
19-26 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Socha, Prof.
Organizational Affiliation
Children's Memorial Health Institute, Warzaw, Poland
Official's Role
Principal Investigator
Facility Information:
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
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