Fit Child - Clinical Study on Weight Control (FITCHI)

Turku University Hospital (TYKS)

Status: Unknown

Conditions: Overweight; Nutrition Disorder, Child; Weight Change, Body

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03196453

T6161/2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Lactobacillus rhamnosus GG

Treatment:

Dietary Supplement: Probiotic

Probiotic and protein

Active Comparator group

Description:

Lactobacillus rhamnosus GG and whey protein isolate

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Probiotic