ObesityNCT02786160
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
A study testing HMO and Dextropur in people with Obesity, run by Glycom A/S at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- HMO and Dextropur
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- HMO, Dextropur
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMODietary supplement
DextropurDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HMO1 | Active comparator | Daily bolus of HMO1 Receives: Dietary Supplement: HMO |
| HMO2 | Active comparator | Daily bolus of HMO2 Receives: Dietary Supplement: HMO |
| Dextropur | Placebo comparator | Daily bolus of Dextropur Receives: Dietary Supplement: Dextropur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in faecal microbiota profile
Measured: 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
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline in haematology
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of HOMA-IR
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of BMI-SDS
Measured: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of fat percentage
Measured: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of waist circumference
Measured: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of hip circumference
Measured: 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
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of specific blood biomarkers related to inflammation
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of specific faecal biomarkers related to inflammation
Measured: Baseline and after 8 weeks of intake, and after 10 months of wash-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycom A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens-Christian Holm, MD, PhD, Principal investigator, Holbaek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786160
- Sponsor's protocol ID
- NATROB
- Other IDs
- SJ-528
- Status last verified
- Dec 2018
- First submitted
- 23 May 2016
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34139746
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02786160
- Acronym / sponsor ID
- NATROB
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Glycom A/SIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HMO1 | Active comparator | Dietary Supplement: HMODaily bolus of HMO1 |
| HMO2 | Active comparator | Dietary Supplement: HMODaily bolus of HMO2 |
| Dextropur | Placebo comparator | Dietary Supplement: DextropurDaily bolus of Dextropur |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMO | Dietary supplement | HMO1, HMO2 |
| Dextropur | Dietary supplement | Dextropur |
Primary outcome
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
13 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Derived from this study: PubMed 34139746Fonvig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Christian Holm, MD, PhD principal investigator
Holbaek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO and Dextropur in people with Obesity, run by Glycom A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.