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

Not Applicable

Completed

• Conditions: Gastrointestinal Symptoms; Gut Microbiota
• Interventions: Dietary Supplement: HMO; Dietary Supplement: Glucose

• Registration Number: NCT01927900
• Lead Sponsor: Glycom A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-23
• Study Start: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMO2	HMO	HMO diluted in water
HMO4	HMO	HMO diluted in water
Glucose	Glucose	Glucose diluted in water
HMO6	HMO	HMO diluted in water
HMO5	HMO	HMO diluted in water
HMO7	HMO	HMO diluted in water
HMO9	HMO	HMO diluted in water
HMO1	HMO	HMO diluted in water
HMO8	HMO	HMO diluted in water
HMO3	HMO	HMO diluted in water

Primary Outcome Measures

Name	Time	Method
Plasma concentration of study product	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.
Concentration of study product in urine	0 and 6 hours post intake	Detectability of study product in urine 6 hours post intake
Change from baseline in faecal microbiota	Baseline and after 2 weeks of intake	Change from baseline in microbiota after 2 weeks of intake
Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)	Baseline and after 2 weeks of intake	Change from baseline in GSRS after 2 weeks of intake
Change from baseline in Bristol Stool form (BSF) scale	Baseline and during intake. Registered daily during study period.	Change from baseline in BSF during intake

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine, Køge Hospital; 🇩🇰 Køge, Denmark