CompletedNCT01927900HMO-VOLUpdated Mar 18, 2015

The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers

An interventional study of HMO and Glucose in Gut Microbiota and Gastrointestinal Symptoms, sponsored by Glycom A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Glycom A/S · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included. The volunteers will be randomized into one of 10 groups, each of 10 participants, consuming either active product in various mixes and doses (9 groups) or placebo product (1 group) for 2 weeks. The 9 groups receiving active product will receive either one of two Human Milk Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of the study is establishing the effects of various compositions and doses of HMOs on the faecal flora and on gastrointestinal symptoms in health adults.

Conditions studied

Gut Microbiota
Gastrointestinal Symptoms

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Keywords

Human milk oligosaccharides
Microbiota
Prebiotics

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's enrollment of 100 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Glycom A/S is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Signed written informed consent
Ability and willingness to understand and comply to the study procedures

Exclusion criteria

Exclusion Criteria:

Participation in a clinical study one month prior to screening visit and throughout the study.
Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
Any gastrointestinal symptom scored >3 on the GSRS during the screening period
A mean score on the total GSRS >2 (i.e. above the population norm value) during the screening period
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, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
Severe psychiatric disease, as judged by the investigator.
Use of highly dosed probiotic supplements (yoghurt allowed) 3 months prior to the study 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.
Pregnant or lactating or wish to become pregnant during the period of the study.
Lack of suitability for participation in the study for any reason as judged by the investigator.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Active comparator
HMO1
HMO diluted in water
Dietary Supplement: HMO
Placebo comparator
Glucose
Glucose diluted in water
Dietary Supplement: Glucose
Active comparator
HMO2
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO3
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO4
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO5
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO6
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO7
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO8
HMO diluted in water
Dietary Supplement: HMO
Active comparator
HMO9
HMO diluted in water
Dietary Supplement: HMO

Interventions

Dietary supplementHMO
Dietary supplementGlucose

What researchers measure

Primary outcomes

Change from baseline in faecal microbiota
Change from baseline in microbiota after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)
Change from baseline in GSRS after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Plasma concentration of study product
Detectability of study product in plasma at 0, 3, 6 and 9 hours post intake.
Time frame: 0, 3, 6, and 9 hours post intake of study product.
Change from baseline in Bristol Stool form (BSF) scale
Change from baseline in BSF during intake
Time frame: Baseline and during intake. Registered daily during study period.
Concentration of study product in urine
Detectability of study product in urine 6 hours post intake
Time frame: 0 and 6 hours post intake

Secondary outcomes

Change in specific biomarkers in serum
Change from baseline in specific biomarkers in serum after two weeks of intake
Time frame: Baseline and after 2 weeks of intake
Number of participants with adverse events
Registration of adverse events during intake of study product.
Time frame: Baseline to end of the 2 weeks of intake
Change in clinical chemistry
Change from baseline in clinical chemistry after two weeks of intake.
Time frame: Baseline and after 2 weeks of intake
Change in specific biomarkers in faeces
Change from baseline in specific biomarkers in faeces after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Change in haematology
Change from baseline in haematology after 2 weeks of intake
Time frame: At baseline and after 2 weeks of intake

Study locations

1 site

Department of Medicine, Køge Hospital
Køge, 4600, Denmark

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01927900
Lead sponsor: Glycom A/S
Responsible party: Sponsor
First posted: Aug 23, 2013
Start date: May 2014
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Mar 18, 2015

Study contacts

Peter Bytzer, MD

principal investigator · Department of Medicine, Køge Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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