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Trial record 1 of 1 for:    NCT02786160
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Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children

This study is currently recruiting participants.
Verified June 2017 by Glycom A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT02786160
First Posted: May 30, 2016
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Glycom A/S
  Purpose

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.


Condition Intervention Phase
Obesity Dietary Supplement: HMO Dietary Supplement: Dextropur Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Glycom A/S:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: May 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HMO1
Daily bolus of HMO1
Dietary Supplement: HMO
Active Comparator: HMO2
Daily bolus of HMO2
Dietary Supplement: HMO
Placebo Comparator: Dextropur
Daily bolus of Dextropur
Dietary Supplement: Dextropur

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786160


Contacts
Contact: Emma Elison, PhD ct@glycom.com

Locations
Denmark
Department of Paediatrics, Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Contact: Jens-Christian Holm, MD, PhD    +45 59484208    jhom@regionsjaelland.dk   
Contact: Cilius Esmann Fonvig, MD, PhD    +45 59484413    crfo@regionsjaelland.dk   
Principal Investigator: Jens-Christian Holm, MD, PhD         
Sub-Investigator: Cilius Esmann Fonvig, MD, PhD         
Sponsors and Collaborators
Glycom A/S
Investigators
Principal Investigator: Jens-Christian Holm, MD, PhD Holbaek Hospital
  More Information

Responsible Party: Glycom A/S
ClinicalTrials.gov Identifier: NCT02786160     History of Changes
Other Study ID Numbers: NATROB
SJ-528 ( Other Identifier: Den Videnskabsetiske Komité for Region Sjaelland )
First Submitted: May 23, 2016
First Posted: May 30, 2016
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No


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