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

T

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

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

Trial contacts and locations

0

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Central trial contact

Erika Isolaur, MD,PhD; Seppo salminen, PhD

Data sourced from clinicaltrials.gov

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