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NCT02722993 Clinical Trial

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

Antibiotic-associated Diarrhea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02722993
Other study ID # ProGastro Kids 16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2016
Est. completion date May 8, 2017

Study information
Verified date September 2018
Source Probi AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date May 8, 2017
Est. primary completion date May 8, 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 11 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotics

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Probi AB

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of loose/watery stools 19-26 days
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