Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children

NCT02786160 — Not applicable, Completed, 75 participants, Glycom A/S

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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

Registry	NCT02786160
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, basic science
Enrollment	75 (Actual)
Sponsor	Glycom A/S (Industry)
Conditions	Obesity
Interventions	HMO, Dextropur (Dietary supplement)
Dates	start 2016-05-01, primary completion 2018-12-01, completion 2018-12-01, first posted 2016-05-30, last updated 2018-12-13
Locations	1 site in Denmark

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
HMO1	Active comparator	Dietary Supplement: HMO	Daily bolus of HMO1
HMO2	Active comparator	Dietary Supplement: HMO	Daily bolus of HMO2
Dextropur	Placebo comparator	Dietary Supplement: Dextropur	Daily bolus of Dextropur

HMO (Dietary supplement)
Dextropur (Dietary supplement)

+Outcome measures

Primary outcomes

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]

Secondary outcomes

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]
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]

+Eligibility

Sex: All, ages: 5 Years to 12 Years

Inclusion Criteria:

1. Informed, written consent by the child's representative(s) and informed verbal assent by the child
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:

1. Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
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.

+Locations (1)

Facility	City	Country	Status
Department of Paediatrics, Holbaek Hospital	Holbæk	Denmark

+Publications

Results publication: 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. PMID 34139746

+Investigators

Jens-Christian Holm, MD, PhD, Principal investigator, Holbaek Hospital