An interventional study of Probiotic in Overweight, Nutrition Disorder, Child and Weight Change, Body, sponsored by Turku University Hospital. Withdrawn at 1 site in Finland. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment
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
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.
Inclusion Criteria: 2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development
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Exclusion Criteria:Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
Lactobacillus rhamnosus GG
Dietary Supplement: Probiotic
Lactobacillus rhamnosus GG and whey protein isolate
Dietary Supplement: Probiotic
Placebo
Dietary Supplement: Probiotic
probiotic and/or placebo intervention in toddlers
Also known as: FITCHI (Fit Child)
weight gain
body weight
Time frame: 3 months
Blood biomarkers
Subar
Time frame: 3 months
Weight change
Weight change
Time frame: 3 months
Plan to share: No — IPD will be shared once the study has been completed and analysed
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Turku University Hospital