CClinicalTrials.gg
Sign In
CompletedNCT02786160Updated Dec 13, 2018

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

An interventional study of HMO and Dextropur in Obesity, sponsored by Glycom A/S. Completed at 1 site in Denmark. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by Glycom A/S · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Glycom A/S is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementHMO
  • Dietary supplementDextropur
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in clinical chemistry

    Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out

  2. Change from baseline in haematology

    Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out

  3. 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

  4. 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

  5. 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

  6. Change from baseline of HOMA-IR

    Time frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

07

Study locations

1 site
  • Department of Paediatrics, Holbaek Hospital
    Holbaek, 4300, Denmark
08

References and documents

Publications

  • 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. PubMed 34139746 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02786160
Lead sponsor
Glycom A/S
Responsible party
Sponsor
First posted
May 30, 2016
Start date
May 2016
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Dec 13, 2018

Study contacts

Jens-Christian Holm, MD, PhD
principal investigator · Holbaek Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Glycom A/S

Start the discussion