Clinical trial NCT01927900: The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Gastrointestinal Symptoms
Keywords: Human milk oligosaccharides
Microbiota
Prebiotics
Lead sponsor: Glycom A/S
Sponsor class: INDUSTRY
First posted: 2013-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in faecal microbiota
timeFrame: Baseline and after 2 weeks of intake
measure: Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline and after 2 weeks of intake
measure: Plasma concentration of study product
timeFrame: 0, 3, 6, and 9 hours post intake of study product.
measure: Change from baseline in Bristol Stool form (BSF) scale
timeFrame: Baseline and during intake. Registered daily during study period.
measure: Concentration of study product in urine
timeFrame: 0 and 6 hours post intake
Secondary outcomes:
measure: Change in specific biomarkers in serum
timeFrame: Baseline and after 2 weeks of intake
measure: Number of participants with adverse events
timeFrame: Baseline to end of the 2 weeks of intake
measure: Change in clinical chemistry
timeFrame: Baseline and after 2 weeks of intake
measure: Change in specific biomarkers in faeces
timeFrame: Baseline and after 2 weeks of intake
measure: Change in haematology
timeFrame: At baseline and after 2 weeks of intake
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Medicine, Køge Hospital
Study officials:
affiliation: Department of Medicine, Køge Hospital
name: Peter Bytzer, MD
role: PRINCIPAL_INVESTIGATOR
References: