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

Glycom A/S75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Change from baseline in clinical chemistry

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

Change from baseline in haematology

Time frame: 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)

Time frame: 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)

Time frame: 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

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

Change from baseline of HOMA-IR

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

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

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

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

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes