Primary objective: Explore, quantify and interpret the effect of 4-week intervention with 2 x 109 spores of BSCU1 on fecal sIgA, in healthy adults, elderly and 3-6 year old children.Secondary objectives:Explore, quantify and interpret the effect of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
normal immune response
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Change in fecal sIgA concentration after 4 weeks intervention, compared to
baseline
Secondary outcome
- Change in fecal sIgA concentration after 2 weeks intervention, compared to
baseline
- Change in the following markers of immune function, after 4 weeks
intervention, compared to baseline, in healthy adults and older subjects:
* Serum cytokine levels (in elderly only)
* Ex vivo cytokines concentration in (LPS-) stimulated and unstimulated whole
blood
* Ex vivo phagocytosis in whole blood (using flow cytometry), expressed as % of
positive monocytes, % positive granulocytes, mean fluorescence intensity
monocytes, and mean fluorescence intensity granulocytes
Background summary
Limited data from clinical studies indicate that the probiotic strain Bacillus
subtilis CU1 may be effective in reducing common infections. To further support
a beneficial effect of BSCU1 on immune function and resistance to infections,
additional clinical studies are required. However, relatively little is known
as yet with regard to the mechanism of action. More insight into such
mechanisms will help to select the most appropriate study design, target
population and outcomes in future controlled intervention studies. Therefore,
the current study aims to explore a range of possible pathways by which BSCU1
could beneficially modulate the immune system, in three target populations
representing the general population.
Study objective
Primary objective: Explore, quantify and interpret the effect of 4-week
intervention with 2 x 109 spores of BSCU1 on fecal sIgA, in healthy adults,
elderly and 3-6 year old children.
Secondary objectives:
Explore, quantify and interpret the effect of 2-week intervention with 2 x 109
spores of BSCU1 on fecal sIgA, in healthy adults, elderly and 3-6 year old
children.
Explore, quantify and interpret the change in the following markers of immune
function, after 4 weeks intervention with 2 x 109 spores of BSCU1, in healthy
adults and older subjects:
* Serum cytokine levels (in elderly only)
* Ex vivo production of cytokines by (LPS-) stimulated whole blood
* Ex vivo phagocytosis in whole blood
Study design
Single-arm study with repeated measures, involving three different populations,
in which each subject serves as its own control
Intervention
All subjects will receive (the content of) one capsule of BSCU1 (containing 2 x
10^9 spores) once daily, for 4 weeks.
Study burden and risks
Parents of the participating children will be invited for 1 screening and 3
site visits, the children will be asked to come to the screening visit for
assessment of height and weight and to the final visit. Parents will collect
fecal samples from their child at 3 timepoints, bring these to the clinical
site, and answer questions on fecal consistency, study product intake and
wellbeing. No invasive measures will be performed. The study product is on the
market in the EU and in the US, and has been approved for children in this age
category. To obtain insight in the immune stimulatory effect in this specific
age group, data need to be collected in this age group and compared with data
from other age categories.
Adults/elderly will attend 1 screening visit and 3 site visits. Fasting blood
samples will be collected at 1 timepoint during 2 site visits. The total amount
of blood collected is 45 ml per visit. Fecal samples will be collected at 3
timepoints and brought to the clinical site. Participants will answer questions
on fecal consistency, study product intake and wellbeing at each site visit.
Rue Gabriel Péri 137
Marq-en-Baroeul 59700
FR
Rue Gabriel Péri 137
Marq-en-Baroeul 59700
FR
Listed location countries
Age
Inclusion criteria
Adults:
Substantial
• 30 <= age <= 49 years
• BMI >= 18.5 and <=25 kg/m2
• In good health as assessed during screening (by questionnaire), and the
medical investigator*s professional judgment
• Non-smoking
Elderly:
Substantial
• 65 <= age <= 79 years
• BMI 22.0 - 28.0 kg/m2
• Generally healthy as assessed during screening (by questionnaire), and the
medical investigator*s professional judgment
• Non-smoking
Procedural (both for adults and elderly):
• Ability to follow Dutch verbal and written instructions
• Signed informed consent
• Willingness to give up blood donation during the entire study
Children:
Substantial
• 3 <= age <= 6 years
• Healthy BMI, cut-off points will be used as indicated by JGZ (BMI jongens en
meisjes | Voedingscentrum)
• Generally healthy as assessed during screening (by parental anamnesis), and
the study physician*s professional judgment
Procedural:
• Parents/caretakers having the ability to follow Dutch verbal and written
instructions
• Signed informed consent
Exclusion criteria
Adults and elderly
Substantial
• Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory
insufficiency, cancer, chronic kidney or liver disease),
• Acute infection in the past month
• Gastrointestinal disorders (e.g., inflammatory bowel disease),
• Acute gastroenteritis in the past 2 months
• Any vaccination in the past month
• Treatment with antibiotics within 2 months of the start of the study,
• Regular use of laxative agents
• Immunodeficiency disorder
• Use of immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic
corticosteroids, antibodies)
• Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to
pre-study screening
• Regular consumption of probiotics within 1 month before start of the study
• Evidence of current excessive alcohol consumption (>4 consumptions/day or >20
consumptions/week) or drug (ab)use
• Mental status that is incompatible with the proper conduct of the study
Procedural:
• Not having a general practitioner, not allowing disclosure of participation
to the general practitioner or not allow to inform the general practitioner
about abnormal results. Participation in any clinical trial including
blood sampling and/or administration of substances starting 1 month prior
to study start and during the entire study.
• Personnel of NIZO or Gnosis by Lesaffre, their partner and their first and
second degree relatives.
Children
Substantial
• Acute respiratory or gastrointestinal or chronic infections
• Chronic systemic or metabolic diseases
• Gastrointestinal disorders (e.g., inflammatory bowel disease),
• Acute gastroenteritis in the past 2 months
• Any vaccination in the past month
• Treatment with antibiotics within 2 months of the start of the study,
• Immunodeficiency disorder
• Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine,
azathioprine, systemic corticosteroids, antibodies)
• Regular use of laxative agents
• Regular consumption of probiotic supplements within 1 month before start of
the study
Procedural:
• Parents or caretakers not having a general practitioner, not allowing
disclosure of participation to the general practitioner or not allowing to
inform the general practitioner about abnormal results.
• Participation in any clinical trial starting 1 month prior to study
start and during the entire study.
• Parents who are personnel of NIZO or Gnosis by Lesaffre, their partner and
their first and second degree relatives.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79890.000.21 |