Fit Child - Clinical Study on Weight Control

NCT ID: NCT03196453

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Overweight Nutrition Disorder, Child Weight Change, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind, placebo controlled,
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic

Lactobacillus rhamnosus GG

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotic and/or placebo intervention in toddlers

Probiotic and protein

Lactobacillus rhamnosus GG and whey protein isolate

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotic and/or placebo intervention in toddlers

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotic and/or placebo intervention in toddlers

Interventions

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Probiotic

probiotic and/or placebo intervention in toddlers

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FITCHI (Fit Child)

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erika Isolauri

Professori

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika Isolauri

Role: PRINCIPAL_INVESTIGATOR

University of Turku, Department of Pediatrics

Locations

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University of Turku and University Hospital Turku

Turku, Varsinaissuomi, Finland

Site Status

Countries

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Finland

Other Identifiers

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T6161/2017

Identifier Type: -

Identifier Source: org_study_id

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