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Completed

NCT Number: NCT01927900

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Køge Hospital

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

HMO

Dietary Supplement

Glucose

Dietary Supplement

Primary outcomes

  1. Change from baseline in faecal microbiota

    Time frame: Baseline and after 2 weeks of intake

    Change from baseline in microbiota after 2 weeks of intake

  2. Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Baseline and after 2 weeks of intake

    Change from baseline in GSRS after 2 weeks of intake

  3. Plasma concentration of study product

    Time frame: 0, 3, 6, and 9 hours post intake of study product.

    Detectability of study product in plasma at 0, 3, 6 and 9 hours post intake.

  4. Change from baseline in Bristol Stool form (BSF) scale

    Time frame: Baseline and during intake. Registered daily during study period.

    Change from baseline in BSF during intake

  5. Concentration of study product in urine

    Time frame: 0 and 6 hours post intake

    Detectability of study product in urine 6 hours post intake

Secondary outcomes

  1. Change in specific biomarkers in serum

    Time frame: Baseline and after 2 weeks of intake

    Change from baseline in specific biomarkers in serum after two weeks of intake

  2. Number of participants with adverse events

    Time frame: Baseline to end of the 2 weeks of intake

    Registration of adverse events during intake of study product.

  3. Change in clinical chemistry

    Time frame: Baseline and after 2 weeks of intake

    Change from baseline in clinical chemistry after two weeks of intake.

  4. Change in specific biomarkers in faeces

    Time frame: Baseline and after 2 weeks of intake

    Change from baseline in specific biomarkers in faeces after 2 weeks of intake

  5. Change in haematology

    Time frame: At baseline and after 2 weeks of intake

    Change from baseline in haematology after 2 weeks of intake

Sponsors and collaborators

Lead sponsor

Glycom A/S

Industry

Registry information

Official study title

THE EFFECTS OF HUMAN-MILK-OLIGOSACCHARIDES ON THE FAECAL MICROBIOTA AND ON GASTROINTESTINAL SYMPTOMS IN HEALTHY VOLUNTEERS A PARALLEL, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED DOSE FINDING STUDY

Acronym: HMO-VOL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2013
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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