Immune System DisordersPhase 1ADELEWP1t4NCT03351543
Effect of Microbial Exposure on Health, Particularly Immune System
A Phase 1 study testing microbial inoculate in people with Immune System Disorders, run by University of Helsinki at 1 site in Finland.
Trial summary
The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Disorders
- What is being tested?
- microbial inoculate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2016to Jul 2017
- Phase
- Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADELE: Autoimmune Defense and Living Environment
The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.
Read the detailed description
The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.
- Conditions
- Immune System Disorders
- Being tested
- microbial inoculate
- Keywords
- vaccine response, immune system activity
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbial inoculateBiological
volunteers will regularly receive microbial inoculate that they do not use orally
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Experimental | these volunteers receive microbial inoculate Receives: Biological: microbial inoculate |
| control | No intervention | these volunteers do not receive microbial inoculate |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in blood serum's cytokine levels
it will be checked if the values are different in different arms
Measured: 1-3 months
difference in blood serum IgE levels
in will be chekced if the values are different in different arms
Measured: 1-3months
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections
Measured: 1-3 months
Secondary outcomes (3)
difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community
it will be analyzed if microbial communities are similar in both arms
Measured: 1-3 months
difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community
it will be analyzed if microbial communities are similar in both arms
Measured: 1-3 months
Number of participants with treatment-related adverse events as assessed by a questionnaire described below
In the end of the experimental period and 2-4 weeks later, all study participants fill a questionnaire. It will be asked if the volunteers experienced a negative change in mental well-being during the study period. Similarly, they will be specifically asked for itches, skin symptoms and signs of infections. And index (how may yes-answers) will be compared between treatment and control groups.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startMar 2016
- Primary completionJun 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DisordersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Aki Sinkkonen, University of Helsinki
- Investigators
- Aki Sinkkonen, Ph D Docent, Study chair, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351543
- Sponsor's protocol ID
- HelsinkiUADELEWP1t4
- Acronym
- ADELEWP1t4
- Status last verified
- Nov 2017
- First submitted
- 23 Mar 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be publicly available according to the instructions of Tekes, the funder. We can publish the data when we know the results and we have to publish it when the project ends.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADELE: Autoimmune Defense and Living Environment
- ClinicalTrials.gov ID
- NCT03351543
- Acronym / sponsor ID
- ADELEWP1t4 / HelsinkiUADELEWP1t4
- Conditions
- Immune System Disorders
- Keywords
- vaccine response, immune system activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Nov 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 effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.
Detailed description
The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | Experimental | Biological: microbial inoculatethese volunteers receive microbial inoculate |
| control | No intervention | –these volunteers do not receive microbial inoculate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| microbial inoculatevolunteers will regularly receive microbial inoculate that they do not use orally | Biological | Exposed group |
Primary outcome
difference in blood serum's cytokine levels
Time frame: 1-3 months
it will be checked if the values are different in different arms
difference in blood serum IgE levels
Time frame: 1-3months
in will be chekced if the values are different in different arms
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
Time frame: 1-3 months
it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections
3 secondary outcomes
difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community
Time frame: 1-3 months
difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community
Time frame: 1-3 months
Number of participants with treatment-related adverse events as assessed by a questionnaire described below
Time frame: 1-3 months
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 24 Nov 2017.
- Individual participant dataSharing planned: Yes. The data will be publicly available according to the instructions of Tekes, the funder. We can publish the data when we know the results and we have to publish it when the project ends.
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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.
Aki Sinkkonen, Ph D Docent study chair
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing microbial inoculate in people with Immune System Disorders, run by University of Helsinki at 1 site in Finland.
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 1 inclusion and 0 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 24 Nov 2017. 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 Finland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
difference in blood serum's cytokine levels (time frame: 1-3 months). The study lists 3 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 24 Nov 2017.