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OpenTrials
Completed

NCT Number: NCT02722993

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

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

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Number of loose/watery stools

    Time frame: 19-26 days

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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