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Completed

NCT Number: NCT02786160

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

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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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics, Holbaek Hospital

Holbæk, 4300, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HMO

Dietary Supplement

Dextropur

Dietary Supplement

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

Sponsors and collaborators

Lead sponsor

Glycom A/S

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 30, 2016
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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