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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786160
• Other study ID #: NATROB
• Secondary ID: SJ-528
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Glycom A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• HMO

• Dextropur

Locations

Country	Name	City	State
Denmark	Department of Paediatrics, Holbaek Hospital	Holbaek

Sponsors (1)

Lead Sponsor	Collaborator
Glycom A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in clinical chemistry		Baseline and after 8 weeks of intake, and after 10 months of wash-out
Secondary	Change from baseline in haematology		Baseline and after 8 weeks of intake, and after 10 months of wash-out
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline of HOMA-IR		Baseline and after 8 weeks of intake, and after 10 months of wash-out
Secondary	Change from baseline of BMI-SDS		Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Secondary	Change from baseline of fat percentage		Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Secondary	Change from baseline of waist circumference		Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Secondary	Change from baseline of hip circumference		Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Secondary	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
Secondary	Change from baseline of specific blood biomarkers related to inflammation		Baseline and after 8 weeks of intake, and after 10 months of wash-out
Secondary	Change from baseline of specific faecal biomarkers related to inflammation		Baseline and after 8 weeks of intake, and after 10 months of wash-out