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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: HMO; Dietary supplement: Dextropur

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holbaek, Denmark, 4300
    • Department of Paediatrics, Holbaek Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Glycom A/S
• Investigators: Principal Investigator: Jens-Christian Holm, MD, PhD, Holbaek Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NATROB; SJ-528 (Other Identifier: Den Videnskabsetiske Komité for Region Sjaelland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No