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

NCT02786160 | Completed

• 2 other identifiers: NATROBSJ-528
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (3)

HMO1

ACTIVE COMPARATOR

Daily bolus of HMO1

Dietary Supplement: HMO

HMO2

ACTIVE COMPARATOR

Daily bolus of HMO2

Dietary Supplement: HMO

Dextropur

PLACEBO COMPARATOR

Daily bolus of Dextropur

Dietary Supplement: Dextropur

Interventions

HMO DIETARY_SUPPLEMENT

HMO1; HMO2

Dextropur DIETARY_SUPPLEMENT

Dextropur

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed, written consent by the child's representative(s) and informed verbal assent by the child
• Age ≥5 and \<11 years at visit 0
• BMI SDS of ≥ 2.3
• Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
• Ability and willingness to understand and comply with the study procedures
• The child's representative(s) need(s) to read, speak and understand Danish

You may not qualify if:

• Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
• Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
• Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
• Psychiatric disease, as judged by the investigator.
• Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
• Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
• 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.
• Lack of suitability for participation in the study for any reason as judged by the investigator.

Sponsors & Collaborators

• Glycom A/S: lead

Study Sites (1)

Department of Paediatrics, Holbaek Hospital

Holbæk, 4300, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34139746 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Health Maintenance Organizations

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Officials

• Jens-Christian Holm, MD, PhD

  Holbaek Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)