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

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ClinicalTrials.gov Identifier: NCT03523936
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
VTT Technical Research Centre of Finland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Changes in the Gut Microbiota During an Antibiotic Treatment Dietary Supplement: Prebiotic product Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled trial
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Prebiotic Dietary Supplement: Prebiotic product
Prebiotic product used during the course of antibiotic treatment

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Changes of gut microbiota during antibiotic treatment [ Time Frame: One week ]
    Gut microbiota and antibiotics - Prevention of side effects by new prebiotics



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523936


Contacts
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Contact: Seppo salminen, PhD +35823336880 sepsal@utu.fi
Contact: Erika Isolaur, MD,PhD +35823130000 eriiso@utu.fi

Sponsors and Collaborators
Turku University Hospital
VTT Technical Research Centre of Finland

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03523936     History of Changes
Other Study ID Numbers: T63/2018
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Turku University Hospital:
antibiotics, prebiotics, dysbiosis

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents