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

Changes in the Gut Microbiota During an Antibiotic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03523936
• Other study ID #: T63/2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: Turku University Hospital
• Contact: Seppo salminen, PhD
• Phone: +35823336880
• Email: sepsal[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Changes in the Gut Microbiota During an Antibiotic Treatment

Intervention

Dietary Supplement:
• Prebiotic product
Prebiotic product used during the course of antibiotic treatment
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	VTT Technical Research Centre of Finland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of gut microbiota during antibiotic treatment	Gut microbiota and antibiotics - Prevention of side effects by new prebiotics	One week