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FITCHI: Fit Child - Clinical Study on Weight Control

Sponsor
Turku University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03196453
Collaborator
University of Turku (Other)
45
Enrollment
1
Location
3
Arms
29
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind, placebo controlled,double blind, placebo controlled,
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
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)

    		•
    Placebo Comparator: Placebo

    Placebo

    Dietary Supplement: Probiotic
    probiotic and/or placebo intervention in toddlers
    Other Names:
  • FITCHI (Fit Child)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. weight gain [3 months]

      body weight

    Secondary Outcome Measures

    1. Blood biomarkers [3 months]

      Subar

    2. Weight change [3 months]

      Weight change

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Turku and University Hospital Turku Turku Varsinaissuomi Finland 20520

    Sponsors and Collaborators

    • Turku University Hospital
    • University of Turku

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erika Isolauri, Professori, Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT03196453
    Other Study ID Numbers:
    • T6161/2017
    First Posted:
    Jun 22, 2017
    Last Update Posted:
    Jun 23, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Erika Isolauri, Professori, Turku University Hospital
    overweight
    probiotic
    weight management
    Additional relevant MeSH terms:
    Nutrition Disorders
    Child Nutrition Disorders
    Overweight
    Body Weight Changes

    Study Results

    No Results Posted as of Jun 23, 2017