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Efficacy 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. Identifier: NCT02722993
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : September 26, 2018
Information provided by (Responsible Party):
Probi AB

Brief Summary:
To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Diarrhea Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : May 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

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

Primary Outcome Measures :
  1. Number of loose/watery stools [ Time Frame: 19-26 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02722993

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Warszawa, Poland
Sponsors and Collaborators
Probi AB
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Principal Investigator: Piotr Socha, Prof. Children's Memorial Health Institute, Warzaw, Poland
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Responsible Party: Probi AB Identifier: NCT02722993    
Other Study ID Numbers: ProGastro Kids 16
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms