Fit Child - Clinical Study on Weight Control (FITCHI)

June 22, 2017 updated by: Erika Isolauri, Turku University Hospital

Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta

Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.

The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.

Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erika Isolauri, MD, PhD
  • Phone Number: +3582313000
  • Email: eriiso@utu.fi

Study Locations

  • Finland
    • Varsinaissuomi
      • Turku, Varsinaissuomi, Finland, 20520
        • University of Turku and University Hospital Turku
        • Contact:
          • Erika Isolauri, MD, PhD
          • Phone Number: +35823130000
          • Email: eriiso@utu.fi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: 2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development

-

Exclusion Criteria:Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Other Names:
  • FITCHI (Fit Child)
ACTIVE_COMPARATOR: Probiotic
Lactobacillus rhamnosus GG
Dietary supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Other Names:
  • FITCHI (Fit Child)
ACTIVE_COMPARATOR: Probiotic and protein
Lactobacillus rhamnosus GG and whey protein isolate
Dietary supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Other Names:
  • FITCHI (Fit Child)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight gain
Time Frame: 3 months
body weight
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood biomarkers
Time Frame: 3 months
Subar
3 months
Weight change
Time Frame: 3 months
Weight change
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku

Investigators

  • Principal Investigator: Erika Isolauri, University of Turku, Department of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (ACTUAL)

June 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T6161/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared once the study has been completed and analysed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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