Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
NCT ID: NCT02786160
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2016-05-31
2018-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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HMO1
Daily bolus of HMO1
HMO
HMO2
Daily bolus of HMO2
HMO
Dextropur
Daily bolus of Dextropur
Dextropur
Interventions
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HMO
Dextropur
Eligibility Criteria
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Inclusion Criteria
2. Age ≥5 and \<11 years at visit 0
3. BMI SDS of ≥ 2.3
4. Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
5. Ability and willingness to understand and comply with the study procedures
6. The child's representative(s) need(s) to read, speak and understand Danish
Exclusion Criteria
2. Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
3. Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
4. Psychiatric disease, as judged by the investigator.
5. Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
6. Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
8. Lack of suitability for participation in the study for any reason as judged by the investigator.
5 Years
12 Years
ALL
No
Sponsors
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Glycom A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Jens-Christian Holm, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Holbaek Hospital
Locations
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Department of Paediatrics, Holbaek Hospital
Holbæk, , Denmark
Countries
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References
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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.
Other Identifiers
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SJ-528
Identifier Type: OTHER
Identifier Source: secondary_id
NATROB
Identifier Type: -
Identifier Source: org_study_id