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

NCT01927900 | Completed

• 2 other identifiers: HMO1-2013SJ-345
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota; Gastrointestinal Symptoms

Keywords

Human milk oligosaccharides; Microbiota; Prebiotics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Change in specific biomarkers in serum

  Baseline and after 2 weeks of intake

• Number of participants with adverse events

  Baseline to end of the 2 weeks of intake

• Change in clinical chemistry

  Baseline and after 2 weeks of intake

• Change in specific biomarkers in faeces

  Baseline and after 2 weeks of intake

• Change in haematology

  At baseline and after 2 weeks of intake

Study Arms (10)

HMO1

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

Glucose

PLACEBO COMPARATOR

Glucose diluted in water

Dietary Supplement: Glucose

HMO2

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO3

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO4

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO5

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO6

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO7

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO8

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

HMO9

ACTIVE COMPARATOR

HMO diluted in water

Dietary Supplement: HMO

Interventions

HMO DIETARY_SUPPLEMENT

HMO1; HMO2; HMO3; HMO4; HMO5; HMO6; HMO7; HMO8; HMO9

Glucose DIETARY_SUPPLEMENT

Glucose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent
• Ability and willingness to understand and comply to the study procedures

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glycom A/S: lead

Study Sites (1)

Department of Medicine, Køge Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Interventions

Health Maintenance Organizations; Glucose

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Peter Bytzer, MD

  Department of Medicine, Køge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 23, 2013
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

DK (1)