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| ID | Type | Description | Link |
|---|---|---|---|
| SJ-528 | Other Identifier | Den Videnskabsetiske Komité for Region Sjaelland |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMO1 | Active Comparator | Daily bolus of HMO1 |
|
| HMO2 | Active Comparator | Daily bolus of HMO2 |
|
| Dextropur | Placebo Comparator | Daily bolus of Dextropur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMO | Dietary Supplement |
| ||
| Dextropur |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in faecal microbiota profile | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinical chemistry | Baseline and after 8 weeks of intake, and after 10 months of wash-out | |
| Change from baseline in haematology | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens-Christian Holm, MD, PhD | Holbaek Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, Holbaek Hospital | Holbæk | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34139746 | Derived | Fonvig CE, Amundsen ID, Vigsnaes LK, Sorensen N, Frithioff-Bojsoe C, Christiansen M, Hedley PL, Holm LA, McConnell B, Holm JC. Human Milk Oligosaccharides Modulate Fecal Microbiota and Are Safe for Use in Children With Overweight: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):408-414. doi: 10.1097/MPG.0000000000003205. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006279 | Health Maintenance Organizations |
| ID | Term |
|---|---|
| D008329 | Managed Care Programs |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
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|
| Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS) | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline in Bristol Stool Form Scale (BSFS) | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline in specific host-bacteria metabolic biomarkers in blood | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
| Change from baseline of HOMA-IR | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
| Change from baseline of BMI-SDS | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline of fat percentage | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline of waist circumference | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline of hip circumference | Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out |
| Change from baseline of specific blood biomarkers related to gut barrier function | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
| Change from baseline of specific blood biomarkers related to inflammation | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
| Change from baseline of specific faecal biomarkers related to inflammation | Baseline and after 8 weeks of intake, and after 10 months of wash-out |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004467 |
| Economics |
| D004472 | Health Care Economics and Organizations |
| D017061 | Prepaid Health Plans |
| D006123 | Group Practice |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |