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
• 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
• 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

Related Conditions & MeSH terms

• Body Weight Changes
• Child Nutrition Disorders
• Nutrition Disorder, Child
• Nutrition Disorders
• Overweight
• Weight Change, Body

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