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CompletedNCT02722993Updated Sep 26, 2018

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

An interventional study of Probiotics and Placebo in Antibiotic-associated Diarrhea, sponsored by Probi AB. Completed at 1 site in Poland. Open to participants aged 1 Year to 11 Years. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
1 Year to 11 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Antibiotic-associated Diarrhea

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03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 117 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Probi AB is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 11 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
117 participants (actual)

Study arms

  • Active comparator
    Probiotics

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Number of loose/watery stools

    Time frame: 19-26 days

07

Study locations

1 site
  • Warszawa, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02722993
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Mar 30, 2016
Start date
Feb 3, 2016
Primary completion
May 8, 2017
Completion
May 8, 2017
Last update
Sep 26, 2018

Study contacts

Piotr Socha, Prof.
principal investigator · Children's Memorial Health Institute, Warzaw, Poland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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