normal immune response immune system
Conditions
Interventions
All subjects will receive (the content of) one capsule of BSCU1 (containing 2 x
10^9 spores) once daily, for 4 weeks.
Sponsors
Gnosis by Lesaffre
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults: Substantial • 30 = 18.5 and
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in fecal sIgA concentration after 4 weeks intervention, compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Netherlands
Outcome results
None listed