Gastrointestinal HealthNCT04758845
Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults
A study testing Cocktail, CGI314 and CSI08 in people with Gastrointestinal Health and Respiratory Health, run by Deerland Enzymes at 1 site in Slovenia.
Trial summary
This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health, Respiratory Health, Safety
- What is being tested?
- Cocktail, CGI314 and CSI08
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 Feb 2021to May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent form. Healthy adults aged 18-65.
Who cannot join
- Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Health Center Nova Gorica
Sempeter pri Gorici, 5290
Lilijana K Besednjak, MD PhD, +38653383466, dos.besednjak@zd-go.si
About this study
Official title: A Randomized, 5 Arm, Parallel, Placebo Controlled Clinical Study to Evaluate Safety and Efficacy of New Probiotic Strains in Healthy Adults
This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.
- Conditions
- Gastrointestinal Health, Respiratory Health, Safety
- Being tested
- Cocktail, CGI314, CSI08, MIT411
- Keywords
- Probiotics, Gastrointestinal Health, Respiratory Health, Immunomodulation, Antioxidant, Chelation of heavy metals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocktailDietary supplement
Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.
CGI314Dietary supplement
Subjects will consume 1B CFU of CGI314 once daily for 45 days.
CSI08Dietary supplement
Subjects will consume 1B CFU of CSI08 once daily for 45 days.
MIT411Dietary supplement
Subjects will consume 1B CFU of MIT411 once daily for 45 days.
| Study group | Role | What they receive |
|---|---|---|
| Cocktail | Experimental | Subjects will consume 1 capsule containing 2B CFU containing .5B CFU Bacillus subtilis DE111, .5B CFU Bacillus coagulans CGI314, .5B CFU Bacillus megaterium MIT411, and .5B CFU Bacillus clausii CSI08 for 45 days. Receives: Dietary Supplement: Cocktail |
| CGI314 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days. Receives: Dietary Supplement: CGI314 |
| CSI08 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days. Receives: Dietary Supplement: CSI08 |
| MIT411 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days. Receives: Dietary Supplement: MIT411 |
| Placebo | No intervention | Subjects will consume 1 capsule containing maltodextrin for 45 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Participants will be asked to note any adverse events that might occur during 45 days study treatment period in the participant diary 1 and 14 days follow-up period in the participant diary 2 and to call the investigator if any clinically significant events occur. The investigator will review the returned participant diaries together with the participant. Based on the adverse events marked in the diaries and written in medical records the number of adverse event occurrences, their nature and causality will be evaluated in all study regimes.
Measured: 45 days
Secondary outcomes (4)
Immunomodulation
Evaluate difference in salivary IgA in experimental groups compared to placebo
Measured: 45 days
Regularity
Evaluate difference in stool consistency according to Bristol stool chart, and regularity of defecation from baseline to day 45 in experimental groups compared to control group and from baseline to end of 14 days follow up period (59 days) in the experimental groups compared to control group. Participants will be asked to track the type of their stool using the bristol stool chart, and times of defecation during the 45 day treatment period and 14 days follow up period in their diaries. On visit 2 and during the follow up phone call the investigator will review the participant diary together with the participant.
Measured: 45 days
GI Health
Assess number of days with gastrointestinal problems in experimental groups compared to placebo.
Measured: 45 days
Respiratory Health
Assess number of days with respiratory infections in experimental groups compared to placebo.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Feb 2021
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
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 Gastrointestinal HealthStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deerland Enzymes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilijana K Besednjak, MD PhD, Principal investigator, Health Center Nova Gorica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758845
- Sponsor's protocol ID
- Pro5Safe
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rea K, Colom J, Simon EA, Khokhlova E, Mazhar S, Barrena M, Enrique M, Martorell P, Perez BA, Tortajada M, Phipps C, Deaton J. Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study. Benef Microbes. 2023 Apr 18;14(2):165-182. doi: 10.3920/BM2022.0117. Epub 2023 Apr 7.
PubMed 37026366
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 5 Arm, Parallel, Placebo Controlled Clinical Study to Evaluate Safety and Efficacy of New Probiotic Strains in Healthy Adults
- ClinicalTrials.gov ID
- NCT04758845
- Acronym / sponsor ID
- Pro5Safe
- Conditions
- Gastrointestinal Health, Respiratory Health, Safety
- Keywords
- Probiotics, Gastrointestinal Health, Respiratory Health, Immunomodulation, Antioxidant, Chelation of heavy metals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Deerland EnzymesIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 17 Feb 2021 (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.
This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cocktail | Experimental | Dietary Supplement: CocktailSubjects will consume 1 capsule containing 2B CFU containing .5B CFU Bacillus subtilis DE111, .5B CFU Bacillus coagulans CGI314, .5B CFU Bacillus megaterium MIT411, and .5B CFU Bacillus clausii CSI08 for 45 days. |
| CGI314 | Experimental | Dietary Supplement: CGI314Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days. |
| CSI08 | Experimental | Dietary Supplement: CSI08Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days. |
| MIT411 | Experimental | Dietary Supplement: MIT411Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days. |
| Placebo | No intervention | –Subjects will consume 1 capsule containing maltodextrin for 45 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent form. Healthy adults aged 18-65.
Key exclusion criteria (1 listed)
- Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.
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 |
|---|---|---|
| CocktailSubjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days. | Dietary supplement | Cocktail |
| CGI314Subjects will consume 1B CFU of CGI314 once daily for 45 days. | Dietary supplement | CGI314 |
| CSI08Subjects will consume 1B CFU of CSI08 once daily for 45 days. | Dietary supplement | CSI08 |
| MIT411Subjects will consume 1B CFU of MIT411 once daily for 45 days. | Dietary supplement | MIT411 |
Primary outcome
Safety
Time frame: 45 days
Participants will be asked to note any adverse events that might occur during 45 days study treatment period in the participant diary 1 and 14 days follow-up period in the participant diary 2 and to call the investigator if any clinically significant events occur. The investigator will review the returned participant diaries together with the participant. Based on the adverse events marked in the diaries and written in medical records the number of adverse event occurrences, their nature and causality will be evaluated in all study regimes.
4 secondary outcomes
Immunomodulation
Time frame: 45 days
Regularity
Time frame: 45 days
GI Health
Time frame: 45 days
Respiratory Health
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 37026366Rea K, Colom J, Simon EA, Khokhlova E, Mazhar S, Barrena M, Enrique M, Martorell P, Perez BA, Tortajada M, Phipps C, Deaton J. Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study. Benef Microbes. 2023 Apr 18;14(2):165-182. doi: 10.3920/BM2022.0117. Epub 2023 Apr 7.
Related trials for Gastrointestinal Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
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 K Besednjak, MD PhD principal investigator
Health Center Nova Gorica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocktail, CGI314 and CSI08 in people with Gastrointestinal Health and Respiratory Health, run by Deerland Enzymes at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilijana K Besednjak, MD PhD (+38653383466, lilijana.besednjak.kocijancic@zd-go.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 45 days). 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 NCT04758845, 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 17 Feb 2021.