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

Gut Microbiota Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927900
• Other study ID #: HMO1-2013
• Secondary ID: SJ-345
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: March 17, 2015
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Glycom A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Gastrointestinal Symptoms
• Gut Microbiota
• Signs and Symptoms, Digestive

Intervention

Dietary Supplement:
• HMO

• Glucose

Locations

Country	Name	City	State
Denmark	Department of Medicine, Køge Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Glycom A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in faecal microbiota	Change from baseline in microbiota after 2 weeks of intake	Baseline and after 2 weeks of intake	No
Primary	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	No
Primary	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.	No
Primary	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.	No
Primary	Concentration of study product in urine	Detectability of study product in urine 6 hours post intake	0 and 6 hours post intake	No
Secondary	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	No
Secondary	Number of participants with adverse events	Registration of adverse events during intake of study product.	Baseline to end of the 2 weeks of intake	Yes
Secondary	Change in clinical chemistry	Change from baseline in clinical chemistry after two weeks of intake.	Baseline and after 2 weeks of intake	Yes
Secondary	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	No
Secondary	Change in haematology	Change from baseline in haematology after 2 weeks of intake	At baseline and after 2 weeks of intake	Yes