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

Turku University Hospital (TYKS)

Status: Unknown

Conditions: Changes in the Gut Microbiota During an Antibiotic Treatment

Treatments: Dietary Supplement: Prebiotic product; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03523936

T63/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Prebiotic

Active Comparator group

Treatment:

Dietary Supplement: Prebiotic product

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo