NCT03523936

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

May 2, 2018

Last Update Submit

May 11, 2018

Conditions

Changes in the Gut Microbiota During an Antibiotic Treatment

Keywords

antibiotics, prebiotics, dysbiosis

Outcome Measures

Primary Outcomes (1)

  • Changes of gut microbiota during antibiotic treatment

    Gut microbiota and antibiotics - Prevention of side effects by new prebiotics

    One week

Study Arms (2)

Prebiotic

ACTIVE COMPARATOR
Dietary Supplement: Prebiotic product

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Prebiotic productDIETARY_SUPPLEMENT

Prebiotic product used during the course of antibiotic treatment

Prebiotic
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • An infection requiring antibiotic treatment assessed by a doctor

You may not qualify if:

  • Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Seppo salminen, PhD

CONTACT

+35823336880sepsal@utu.fi

Erika Isolaur, MD,PhD

CONTACT

+35823130000eriiso@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind placebo controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

June 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 14, 2018

Record last verified: 2018-05