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

NCT ID: NCT03523936

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Changes in the Gut Microbiota During an Antibiotic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prebiotic

Group Type ACTIVE_COMPARATOR

Prebiotic product

Intervention Type DIETARY_SUPPLEMENT

Prebiotic product used during the course of antibiotic treatment

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Prebiotic product

Prebiotic product used during the course of antibiotic treatment

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VTT Technical Research Centre of Finland

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Seppo salminen, PhD

Role: CONTACT

+35823336880

Erika Isolaur, MD,PhD

Role: CONTACT

+35823130000

Other Identifiers

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T63/2018

Identifier Type: -

Identifier Source: org_study_id

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