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

Glycom

Status: Completed

Conditions: Gut Microbiota; Gastrointestinal Symptoms

Treatments: Dietary Supplement: HMO; Dietary Supplement: Glucose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01927900

SJ-345 (Other Identifier)

HMO1-2013

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 10 patient groups, including a placebo group

HMO1

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

Glucose

Placebo Comparator group

Description:

Glucose diluted in water

Treatment:

Dietary Supplement: Glucose

HMO2

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO3

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO4

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO5

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO6

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO7

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO8

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO

HMO9

Active Comparator group

Description:

HMO diluted in water

Treatment:

Dietary Supplement: HMO