Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 344 for:    Recruiting, Not yet recruiting, Available Studies | "nutrition disorders" | Child

Fit Child - Clinical Study on Weight Control (FITCHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03196453
Recruitment Status : Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Erika Isolauri, Turku University Hospital

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
Overweight Nutrition Disorder, Child Weight Change, Body Dietary Supplement: Probiotic Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind, placebo controlled,
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Probiotic
Lactobacillus rhamnosus GG
Dietary Supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Other Name: 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 Name: FITCHI (Fit Child)

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Other Name: FITCHI (Fit Child)




Primary Outcome Measures :
  1. weight gain [ Time Frame: 3 months ]
    body weight


Secondary Outcome Measures :
  1. Blood biomarkers [ Time Frame: 3 months ]
    Subar

  2. Weight change [ Time Frame: 3 months ]
    Weight change



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196453


Contacts
Layout table for location contacts
Contact: seppo Salminen, PhD +35823336880 sepsal@utu.fi
Contact: Erika Isolauri, MD, PhD +3582313000 eriiso@utu.fi

Locations
Layout table for location information
Finland
University of Turku and University Hospital Turku Not yet recruiting
Turku, Varsinaissuomi, Finland, 20520
Contact: Erika Isolauri, MD, PhD    +35823130000    eriiso@utu.fi   
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
Layout table for investigator information
Principal Investigator: Erika Isolauri University of Turku, Department of Pediatrics

Layout table for additonal information
Responsible Party: Erika Isolauri, Professori, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03196453     History of Changes
Other Study ID Numbers: T6161/2017
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared once the study has been completed and analysed

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erika Isolauri, Turku University Hospital:
overweight
probiotic
weight management

Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight Changes
Nutrition Disorders
Child Nutrition Disorders
Body Weight
Signs and Symptoms