Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Bonn | OTHER |
Not provided
Not provided
Not provided
Not provided
Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a "balanced" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | HMO bolus administration |
|
| Control | Experimental | bolus administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Milk Oligosaccharides (HMOs) | Dietary Supplement | HMOs will be applied as a neutral-flavoured powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of HMOs | Concentration of HMOs in blood | through study completion, an average of 1 year |
| Excretion of HMOs | Concentration of HMOs in urine | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolism | Concentration of metabolic markers in blood | through study completion, an average of 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Christine Simon, Jun. Prof. | Contact | +49 228 733814 | mcsimon@uni-bonn.de | |
| Sabrina Schenk, M.Sc. | Contact | + 49 228 734598 | sschenk@uni-bonn.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheinische Friedrich-Wilhelms Universität Bonn | Recruiting | Bonn | 53115 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two or more interventions, each alone and in combination, are evaluated in parallel
Not provided
Not provided
Participants are blinded to the supplement.
| Control | Dietary Supplement | will be applied as powder |
|