The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers (HMO-VOL)

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

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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiota; Gastrointestinal Symptoms
• Intervention / Treatment: Dietary supplement: Glucose; Dietary supplement: HMO

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Department of Medicine, Køge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in faecal microbiota	Change from baseline in microbiota after 2 weeks of intake	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	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.	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	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	0 and 6 hours post intake

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Glycom A/S
• Investigators: Principal Investigator: Peter Bytzer, MD, Department of Medicine, Køge Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Microbiota; Prebiotics; Human milk oligosaccharides
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive
• Other Study ID Numbers: HMO1-2013; SJ-345 (Other Identifier: The Scientific Ethical Comitee of Regional Zealand)