Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics

Not Applicable

• Conditions: Changes in the Gut Microbiota During an Antibiotic Treatment
• Interventions: Dietary Supplement: Prebiotic product; Dietary Supplement: Placebo

• Registration Number: NCT03523936
• Lead Sponsor: Turku University Hospital

Brief Summary

Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.

Detailed Description

Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.

The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Study First Posted: 2018-05-14
• Last Update Posted: 2018-05-14
• Study Start: 2018-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• An infection requiring antibiotic treatment assessed by a doctor

Exclusion Criteria

• Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prebiotic	Prebiotic product	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes of gut microbiota during antibiotic treatment	One week	Gut microbiota and antibiotics - Prevention of side effects by new prebiotics