Clinical trial NCT02786160: Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Glycom A/S
Sponsor class: INDUSTRY
First posted: 2016-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in faecal microbiota profile
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Secondary outcomes:
measure: Change from baseline in clinical chemistry
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline in haematology
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS)
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline in Bristol Stool Form Scale (BSFS)
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline in specific host-bacteria metabolic biomarkers in blood
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline of HOMA-IR
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline of BMI-SDS
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline of fat percentage
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline of waist circumference
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline of hip circumference
timeFrame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
measure: Change from baseline of specific blood biomarkers related to gut barrier function
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline of specific blood biomarkers related to inflammation
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
measure: Change from baseline of specific faecal biomarkers related to inflammation
timeFrame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Department of Paediatrics, Holbaek Hospital
Study officials:
affiliation: Holbaek Hospital
name: Jens-Christian Holm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.