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NCT03196453 Clinical Trial

Fit Child - Clinical Study on Weight Control

Overweight Clinical Trial

— FITCHI  

Official title:
Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03196453
Other study ID # T6161/2017
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 20, 2017
Last updated June 22, 2017
Start date August 1, 2017
Est. completion date December 31, 2019

Study information
Verified date June 2017
Source Turku University Hospital
Contact seppo Salminen, PhD
Phone +35823336880
Email sepsal@utu.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 45
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 5 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotic
probiotic and/or placebo intervention in toddlers

Locations
Country Name City State
Finland University of Turku and University Hospital Turku Turku Varsinaissuomi

Sponsors (2)
Lead Sponsor Collaborator
Turku University Hospital University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight gain body weight 3 months
Secondary Blood biomarkers Subar 3 months
Secondary Weight change Weight change 3 months
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