Fit Child - Clinical Study on Weight Control

Study Overview
=================
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

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.

Official Title
-----------------
Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta

Conditions
-----------------
Overweight, Nutrition Disorder, Child, Weight Change, Body

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind, placebo controlled,
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Lactobacillus rhamnosus GG | Dietary Supplement: Probiotic<br>* probiotic and/or placebo intervention in toddlers<br>* Other names: FITCHI (Fit Child);|
| Active Comparator: Probiotic and protein<br>Lactobacillus rhamnosus GG and whey protein isolate | Dietary Supplement: Probiotic<br>* probiotic and/or placebo intervention in toddlers<br>* Other names: FITCHI (Fit Child);|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Probiotic<br>* probiotic and/or placebo intervention in toddlers<br>* Other names: FITCHI (Fit Child);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain | body weight | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biomarkers | Subar | 3 months | 
| Weight change | Weight change | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, probiotic, weight management