Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
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ClinicalTrials.gov Identifier: NCT02786160 |
Recruitment Status :
Completed
First Posted : May 30, 2016
Last Update Posted : December 13, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Dietary Supplement: HMO Dietary Supplement: Dextropur | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HMO1
Daily bolus of HMO1
|
Dietary Supplement: HMO |
Active Comparator: HMO2
Daily bolus of HMO2
|
Dietary Supplement: HMO |
Placebo Comparator: Dextropur
Daily bolus of Dextropur
|
Dietary Supplement: Dextropur |
- Change from baseline in faecal microbiota profile [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
- Change from baseline in clinical chemistry [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline in haematology [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline of HOMA-IR [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline of BMI-SDS [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
- Change from baseline of fat percentage [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
- Change from baseline of waist circumference [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
- Change from baseline of hip circumference [ Time Frame: 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 [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline of specific blood biomarkers related to inflammation [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
- Change from baseline of specific faecal biomarkers related to inflammation [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]

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Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed, written consent by the child's representative(s) and informed verbal assent by the child
- Age ≥5 and <11 years at visit 0
- BMI SDS of ≥ 2.3
- Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
- Ability and willingness to understand and comply with the study procedures
- The child's representative(s) need(s) to read, speak and understand Danish
Exclusion Criteria:
- Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
- Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
- Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
- Psychiatric disease, as judged by the investigator.
- Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
- Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
- 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.
- Lack of suitability for participation in the study for any reason as judged by the investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786160
Denmark | |
Department of Paediatrics, Holbaek Hospital | |
Holbaek, Denmark, 4300 |
Principal Investigator: | Jens-Christian Holm, MD, PhD | Holbaek Hospital |
Responsible Party: | Glycom A/S |
ClinicalTrials.gov Identifier: | NCT02786160 |
Other Study ID Numbers: |
NATROB SJ-528 ( Other Identifier: Den Videnskabsetiske Komité for Region Sjaelland ) |
First Posted: | May 30, 2016 Key Record Dates |
Last Update Posted: | December 13, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |