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

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.

Study Overview

• Status: Unknown
• Conditions: Changes in the Gut Microbiota During an Antibiotic Treatment
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Prebiotic product

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erika Isolaur, MD,PhD; Phone Number: +35823130000; Email: eriiso@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Active Comparator: Prebiotic	Dietary supplement: Prebiotic product; Prebiotic product used during the course of antibiotic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of gut microbiota during antibiotic treatment	Gut microbiota and antibiotics - Prevention of side effects by new prebiotics	One week

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: VTT Technical Research Centre of Finland

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: antibiotics, prebiotics, dysbiosis
• Other Study ID Numbers: T63/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No