Department of Paediatrics, Holbaek Hospital
Holbæk, 4300, Denmark
NCT Number: NCT02786160
The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).
The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.
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Notify Me5 year–12 year
All sexes
Interventional
Not applicable
Holbæk, 4300, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Glycom A/S
Industry
The Effects of Human Milk Oligosaccharides (HMO) on the Faecal Microbiota and on Host Metabolism in Obese Children: A Parallel, Double-blind, Randomized, Placebo-controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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