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OpenTrials
Completed

NCT Number: NCT01940913

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

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.

Completed

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Key information

Conditions

Antibiotic-associated Loose/Watery Stools Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Multicenter study at 13 health care centers in Warsaw

Warsaw, Poland

Who can participate

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

Inclusion criteria

  • Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
  • Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
  • Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

  • Chronic intestinal disease.
  • Current immunodeficiency or immunosuppressive treatment.
  • Chronic or acute diarrhoeal disease.
  • Use of laxatives the week before inclusion in the study.
  • Antibiotic treatment for the last four weeks before inclusion in the study.
  • Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
  • Intake of any probiotic products for the last two weeks before inclusion in the study.
  • Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.

Treatment and study plan

Probiotic capsules

Dietary Supplement

Placebo capsules

Dietary Supplement

Primary outcomes

  1. Reduction of the incidence of loose/watery stools following antibiotic treatment in children.

    Time frame: 19-24 days

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2013
Registry last updated
May 9, 2014

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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