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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gut Microbiota, Gastrointestinal Symptoms

Intervention / Treatment
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* Dietary Supplement: HMO
* Dietary Supplement: Glucose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HMO1<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Placebo Comparator: Glucose<br>Glucose diluted in water | Dietary Supplement: Glucose<br> <br> |
| Active Comparator: HMO2<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO3<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO4<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO5<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO6<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO7<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO8<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |
| Active Comparator: HMO9<br>HMO diluted in water | Dietary Supplement: HMO<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of participants with adverse events | Registration of adverse events during intake of study product. | Baseline to end of the 2 weeks of intake | 
| Change in clinical chemistry | Change from baseline in clinical chemistry after two weeks of intake. | Baseline and after 2 weeks of intake | 
| 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 | 
| Change in haematology | Change from baseline in haematology after 2 weeks of intake | At baseline and after 2 weeks of intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Human milk oligosaccharides, Prebiotics