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

Glycom

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: HMO; Dietary Supplement: Dextropur

Study type: Interventional

Funder types: Industry

Identifiers

NCT02786160

SJ-528 (Other Identifier)

NATROB

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

HMO1

Active Comparator group

Description:

Daily bolus of HMO1

Treatment:

Dietary Supplement: HMO

HMO2

Active Comparator group

Description:

Daily bolus of HMO2

Treatment:

Dietary Supplement: HMO

Dextropur

Placebo Comparator group

Description:

Daily bolus of Dextropur

Treatment:

Dietary Supplement: Dextropur