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

December 11, 2018 updated by: Glycom A/S

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holbaek, Denmark, 4300
        • Department of Paediatrics, Holbaek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in clinical chemistry
Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out
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
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
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
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
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
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
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
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
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
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
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
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
Baseline and after 8 weeks of intake, and after 10 months of wash-out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glycom A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens-Christian Holm, MD, PhD, Holbaek Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NATROB
  • SJ-528 (Other Identifier: Den Videnskabsetiske Komité for Region Sjaelland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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