Gut MicrobiotaHMO-VOLNCT01927900
The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers
A study testing HMO and Glucose in people with Gut Microbiota and Gastrointestinal Symptoms, run by Glycom A/S at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Gastrointestinal Symptoms
- What is being tested?
- HMO and Glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed written informed consent
- Ability and willingness to understand and comply to the study procedures
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- HMO, Glucose
- Keywords
- Human milk oligosaccharides, Microbiota, Prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMODietary supplement
GlucoseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HMO1 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| Glucose | Placebo comparator | Glucose diluted in water Receives: Dietary Supplement: Glucose |
| HMO2 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO3 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO4 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO5 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO6 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO7 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO8 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
| HMO9 | Active comparator | HMO diluted in water Receives: Dietary Supplement: HMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in faecal microbiota
Change from baseline in microbiota after 2 weeks of intake
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 0 and 6 hours post intake
Secondary outcomes (5)
Change in specific biomarkers in serum
Change from baseline in specific biomarkers in serum after two weeks of intake
Measured: Baseline and after 2 weeks of intake
Number of participants with adverse events
Registration of adverse events during intake of study product.
Measured: Baseline to end of the 2 weeks of intake
Change in clinical chemistry
Change from baseline in clinical chemistry after two weeks of intake.
Measured: 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
Measured: Baseline and after 2 weeks of intake
Change in haematology
Change from baseline in haematology after 2 weeks of intake
Measured: At baseline and after 2 weeks of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycom A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bytzer, MD, Principal investigator, Department of Medicine, Køge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927900
- Sponsor's protocol ID
- HMO1-2013
- Other IDs
- SJ-345
- Acronym
- HMO-VOL
- Status last verified
- Mar 2015
- First submitted
- 13 Aug 2013
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01927900
- Acronym / sponsor ID
- HMO-VOL / HMO1-2013
- Conditions
- Gut Microbiota, Gastrointestinal Symptoms
- Keywords
- Human milk oligosaccharides, Microbiota, Prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Glycom A/SIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| HMO1 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| Glucose | Placebo comparator | Dietary Supplement: GlucoseGlucose diluted in water |
| HMO2 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO3 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO4 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO5 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO6 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO7 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO8 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
| HMO9 | Active comparator | Dietary Supplement: HMOHMO diluted in water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signed written informed consent
- Ability and willingness to understand and comply to the study procedures
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMO | Dietary supplement | HMO1, HMO2, HMO3, HMO4, HMO5, HMO6, HMO7, HMO8, HMO9 |
| Glucose | Dietary supplement | Glucose |
Primary outcome
Change from baseline in faecal microbiota
Time frame: 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)
Time frame: Baseline and after 2 weeks of intake
Change from baseline in GSRS after 2 weeks of intake
Plasma concentration of study product
Time frame: 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.
Change from baseline in Bristol Stool form (BSF) scale
Time frame: Baseline and during intake. Registered daily during study period.
Change from baseline in BSF during intake
Concentration of study product in urine
Time frame: 0 and 6 hours post intake
Detectability of study product in urine 6 hours post intake
5 secondary outcomes
Change in specific biomarkers in serum
Time frame: Baseline and after 2 weeks of intake
Number of participants with adverse events
Time frame: Baseline to end of the 2 weeks of intake
Change in clinical chemistry
Time frame: Baseline and after 2 weeks of intake
Change in specific biomarkers in faeces
Time frame: Baseline and after 2 weeks of intake
Change in haematology
Time frame: At baseline and after 2 weeks of intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bytzer, MD principal investigator
Department of Medicine, Køge Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO and Glucose in people with Gut Microbiota and Gastrointestinal Symptoms, run by Glycom A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in faecal microbiota (time frame: Baseline and after 2 weeks of intake). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.