Immune System SupportIMMUNOFORMNCT04077034
Effect of Probiotic Formula DE111® on Immune System in Preschool Children
A study testing Probiotic Formula Bacillus subtilis DE111® in people with Immune System Support, run by Deerland Enzymes at 5 sites in Slovenia.
Trial summary
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Support
- What is being tested?
- Probiotic Formula Bacillus subtilis DE111®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesSlovenia
- Study dates
- 2 Apr 2019to 12 Aug 2019
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- signed informed consent by at least one parent or legal guardian
- children aged 2 to 6 years
- attending or about to start attending day-care
Who cannot join
- body weight at birth <2500g
- gestational age <37 weeks
- severe chronic illness
- regular use of medication
- immunodeficiency
- parent or legal guardian not able to understand and comply with requirements of the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Slovenia5 sites
Health center Laško
Laško, 3270
Pediatrija Krebs
Maribor, 2000
Pediatrinja d.o.o.
Maribor, 2000
Zasebna otroska in solska ambulanta
Maribor, 2230
Health Center Nova Gorica
Sempeter pri Gorici, 5290
About this study
Official title: A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
- Conditions
- Immune System Support
- Being tested
- Probiotic Formula Bacillus subtilis DE111®, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula Bacillus subtilis DE111®Dietary supplement
Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
Placebo comparatorDietary supplement
Placebo comparator, once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Probiotic DE111® Receives: Dietary Supplement: Probiotic Formula Bacillus subtilis DE111® |
| Control group | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
Measured: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
The incidence of adverse events occuring in the experimental group compared to control group
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.
Measured: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start2 Apr 2019
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System SupportStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deerland Enzymes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vizera d.o.o., University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Lilijana Kocijancic Besednjak, MD, PhD, Principal investigator, Health Center Nova Gorica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077034
- Sponsor's protocol ID
- IMMUNO-01
- Acronym
- IMMUNOFORM
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
- ClinicalTrials.gov ID
- NCT04077034
- Acronym / sponsor ID
- IMMUNOFORM / IMMUNO-01
- Conditions
- Immune System Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Deerland EnzymesIndustry (pharma, biotech, devices)
- Collaborators
- Vizera d.o.o., University of Ljubljana
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 4 Sep 2019 (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.
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®Probiotic DE111® |
| Control group | Placebo comparator | Dietary Supplement: Placebo comparatorPlacebo |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- signed informed consent by at least one parent or legal guardian
- children aged 2 to 6 years
- attending or about to start attending day-care
Key exclusion criteria (6 listed)
- body weight at birth <2500g
- gestational age <37 weeks
- severe chronic illness
- regular use of medication
- immunodeficiency
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 |
|---|---|---|
| Probiotic Formula Bacillus subtilis DE111®Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks | Dietary supplement | Experimental group |
| Placebo comparatorPlacebo comparator, once a day for 8 weeks | Dietary supplement | Control group |
Primary outcome
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
Time frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
The incidence of adverse events occuring in the experimental group compared to control group
Time frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.
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 4 Sep 2019.
- 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.
Lilijana Kocijancic Besednjak, MD, PhD principal investigator
Health Center Nova Gorica
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Formula Bacillus subtilis DE111® in people with Immune System Support, run by Deerland Enzymes at 5 sites in Slovenia.
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 3 inclusion and 6 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Slovenia. 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?
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group (time frame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)). The study lists 2 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 4 Sep 2019.