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

Primary Purpose

Gut Microbiota, Gastrointestinal Symptoms

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

HMO

Glucose

About this trial

This is an interventional basic science trial for Gut Microbiota focused on measuring Human milk oligosaccharides, Microbiota, Prebiotics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of Medicine, Køge Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

HMO1

Glucose

HMO2

HMO3

HMO4

HMO5

HMO6

HMO7

HMO8

HMO9

Arm Description

HMO diluted in water

Glucose diluted in water

HMO diluted in water

Outcomes

Primary Outcome Measures

Change from baseline in faecal microbiota

Change from baseline in microbiota 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

Plasma concentration of study product

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

Change from baseline in Bristol Stool form (BSF) scale

Change from baseline in BSF during intake

Concentration of study product in urine

Detectability of study product in urine 6 hours post intake

Secondary Outcome Measures

Change in specific biomarkers in serum

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

Number of participants with adverse events

Registration of adverse events during intake of study product.

Change in clinical chemistry

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

Change in specific biomarkers in faeces

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

Change in haematology

Change from baseline in haematology after 2 weeks of intake

Full Information

NCT ID

NCT01927900

First Posted

August 13, 2013

Last Updated

March 17, 2015

Sponsor

Glycom A/S

1. Study Identification

Unique Protocol Identification Number

NCT01927900

Brief Title

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

Acronym

HMO-VOL

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glycom A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gut Microbiota, Gastrointestinal Symptoms

Keywords

Human milk oligosaccharides, Microbiota, Prebiotics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HMO1

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

Glucose

Arm Type

Placebo Comparator

Arm Description

Glucose diluted in water

Arm Title

HMO2

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO3

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO4

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO5

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO6

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO7

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO8

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Arm Title

HMO9

Arm Type

Active Comparator

Arm Description

HMO diluted in water

Intervention Type

Dietary Supplement

Intervention Name(s)

HMO

Intervention Type

Dietary Supplement

Intervention Name(s)

Glucose

Primary Outcome Measure Information:

Title

Change from baseline in faecal microbiota

Description

Change from baseline in microbiota after 2 weeks of intake

Time Frame

Baseline and after 2 weeks of intake

Title

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

Description

Change from baseline in GSRS after 2 weeks of intake

Time Frame

Baseline and after 2 weeks of intake

Title

Plasma concentration of study product

Description

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.

Title

Change from baseline in Bristol Stool form (BSF) scale

Description

Change from baseline in BSF during intake

Time Frame

Baseline and during intake. Registered daily during study period.

Title

Concentration of study product in urine

Description

Detectability of study product in urine 6 hours post intake

Time Frame

0 and 6 hours post intake

Secondary Outcome Measure Information:

Title

Change in specific biomarkers in serum

Description

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

Time Frame

Baseline and after 2 weeks of intake

Title

Number of participants with adverse events

Description

Registration of adverse events during intake of study product.

Time Frame

Baseline to end of the 2 weeks of intake

Title

Change in clinical chemistry

Description

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

Time Frame

Baseline and after 2 weeks of intake

Title

Change in specific biomarkers in faeces

Description

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

Time Frame

Baseline and after 2 weeks of intake

Title

Change in haematology

Description

Change from baseline in haematology after 2 weeks of intake

Time Frame

At baseline and after 2 weeks of intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Bytzer, MD

Organizational Affiliation

Department of Medicine, Køge Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medicine, Køge Hospital

City

Køge

ZIP/Postal Code

4600

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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