Healthy Response to ProbioticsNCT03140878
Defining the Normal Human Response to Probiotics
A study testing LGG in people with Healthy Response to Probiotics, run by Chr Hansen at 1 site in Denmark.
Trial summary
The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Response to Probiotics
- What is being tested?
- LGG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Apr 2017to 11 Jun 2017
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women
- No medication
- Age between 18 and 35 years
- BMI below 30
- Provided voluntary written informed consent
Who cannot join
- All clinical diagnoses and disorders requiring medicine
- Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.
- Pregnant and women who are breast-feeding
- Patient with known blood clothing disorders
- Patients with clinical psychiatric diagnoses (including dementia)
- Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy
Show all 18Show fewer
- Individuals with high blood pressure (≥140 mmHg /90 mmHg)
- Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months
- Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening
- Usage of medications, except oral contraceptives, during the 14 days prior to screening
- Lactose intolerance
- Participation in other clinical trials in the past three months
- Regular use of probiotics in the last 6 weeks
- Smoking
- Planned changes to current diet or exercise regime
- Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening
- Use of immunosuppressant drugs within last 4 weeks prior to screening
- Ulcer or malignancy in the intestine which is discovered during second visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions
The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells
Read the detailed description
The study includes 3 visits. The first visit serves to check inclusion/exclusion criteria/complete questionnaire/give information about the study and receive consent. At visit 2 and 3 the included individuals will drink a placebo blend or a drink containing Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper intestine during endoscopy while under nurse administered propofol sedation (NAPS). There will be four weeks between visit 2 and 3.
At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will be collected, and one blood sample will be collected.
The down stream analysis will include a combination of gene expression analysis, microbiome analysis and classification of the individuals based on analysis of blood samples.
- Conditions
- Healthy Response to Probiotics
- Being tested
- LGG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGGDietary supplement
LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)
PlaceboDietary supplement
Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)
| Study group | Role | What they receive |
|---|---|---|
| LGG | Experimental | Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water Receives: Dietary Supplement: LGG |
| Placebo | Placebo comparator | The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome-wide gene expression
The effect of LGG on genome-wide gene expression in intestinal tissue and cells
Measured: 3 years
Secondary outcomes (1)
16S analysis of luminal fluid
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start16 Apr 2017
- Primary completion11 Jun 2017
- Study completion11 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Response to ProbioticsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, Herlev Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140878
- Sponsor's protocol ID
- HND-GI-024
- Other IDs
- H-17002470
- Status last verified
- Apr 2018
- First submitted
- 1 May 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bornholdt J, Broholm C, Chen Y, Rago A, Sloth S, Hendel J, Melsaether C, Muller CV, Juul Nielsen M, Strickertsson J, Engelholm L, Vitting-Seerup K, Jensen KB, Baker A, Sandelin A. Personalized B cell response to the Lactobacillus rhamnosus GG probiotic in healthy human subjects: a randomized trial. Gut Microbes. 2020 Nov 9;12(1):1-14. doi: 10.1080/19490976.2020.1854639.
PubMed 33274667
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions
- ClinicalTrials.gov ID
- NCT03140878
- Acronym / sponsor ID
- HND-GI-024
- Conditions
- Healthy Response to Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, Herlev Hospital
- Study start
- 16 Apr 2017 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 11 Jun 2017 (actual)
- First posted
- 4 May 2017 (actual)
- 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 mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells
Detailed description
The study includes 3 visits. The first visit serves to check inclusion/exclusion criteria/complete questionnaire/give information about the study and receive consent. At visit 2 and 3 the included individuals will drink a placebo blend or a drink containing Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper intestine during endoscopy while under nurse administered propofol sedation (NAPS). There will be four weeks between visit 2 and 3.
At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will be collected, and one blood sample will be collected.
The down stream analysis will include a combination of gene expression analysis, microbiome analysis and classification of the individuals based on analysis of blood samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG | Experimental | Dietary Supplement: LGGLactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men or women
- No medication
- Age between 18 and 35 years
- BMI below 30
- Provided voluntary written informed consent
Key exclusion criteria (18 listed)
- All clinical diagnoses and disorders requiring medicine
- Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.
- Pregnant and women who are breast-feeding
- Patient with known blood clothing disorders
- Patients with clinical psychiatric diagnoses (including dementia)
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 |
|---|---|---|
| LGGLGG is dissolved in water and consumed at one occasion (either at visit 2 or 3) | Dietary supplement | LGG |
| PlaceboPlacebo is dissolved in water and consumed at one occasion (either at visit 2 or 3) | Dietary supplement | Placebo |
Primary outcome
Genome-wide gene expression
Time frame: 3 years
The effect of LGG on genome-wide gene expression in intestinal tissue and cells
1 secondary outcome
16S analysis of luminal fluid
Time frame: 3 years
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 23 Apr 2018.
- Derived from this study: PubMed 33274667Bornholdt J, Broholm C, Chen Y, Rago A, Sloth S, Hendel J, Melsaether C, Muller CV, Juul Nielsen M, Strickertsson J, Engelholm L, Vitting-Seerup K, Jensen KB, Baker A, Sandelin A. Personalized B cell response to the Lactobacillus rhamnosus GG probiotic in healthy human subjects: a randomized trial. Gut Microbes. 2020 Nov 9;12(1):1-14. doi: 10.1080/19490976.2020.1854639.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGG in people with Healthy Response to Probiotics, run by Chr Hansen 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 5 inclusion and 18 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 23 Apr 2018. 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?
Genome-wide gene expression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140878, which also lists 1 linked publication.
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 23 Apr 2018.