Change in markers of immune function associated with Bacillus subtilis CU1 intervention in different age groups
- Conditions
- normal immune responseimmune system
- Registration Number
- NL-OMON51589
- Lead Sponsor
- Gnosis by Lesaffre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Change in fecal sIgA concentration after 4 weeks intervention, compared to<br /><br>baseline</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Change in fecal sIgA concentration after 2 weeks intervention, compared to<br /><br>baseline<br /><br>- Change in the following markers of immune function, after 4 weeks<br /><br>intervention, compared to baseline, in healthy adults and older subjects:<br /><br>* Serum cytokine levels (in elderly only)<br /><br>* Ex vivo cytokines concentration in (LPS-) stimulated and unstimulated whole<br /><br>blood<br /><br>* Ex vivo phagocytosis in whole blood (using flow cytometry), expressed as % of<br /><br>positive monocytes, % positive granulocytes, mean fluorescence intensity<br /><br>monocytes, and mean fluorescence intensity granulocytes</p><br>