Rheinische Friedrich-Wilhelms Universität Bonn
Bonn, 53115, Germany
Location status: Recruiting
NCT Number: NCT06495255
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.
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Bonn, 53115, Germany
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HMOs will be applied as a neutral-flavoured powder
will be applied as powder
Time frame: through study completion, an average of 1 year
Concentration of HMOs in blood
Time frame: through study completion, an average of 1 year
Concentration of HMOs in urine
Time frame: through study completion, an average of 1 year
Concentration of metabolic markers in blood
Contact information is provided by the study sponsor or research team.
Marie-Christine Simon, Jun. Prof.
CONTACT
Sabrina Schenk, M.Sc.
CONTACT
University of Bonn
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07686393
Healthy
Bethesda, Maryland, United States
View Trial DetailsNCT07669077
Healthy
Salt Lake City, Utah, United States
View Trial DetailsNCT07169630
Alzheimer s Disease, Cognition Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT07739238
Healthy
Balıkesir, In the USA Or Canada, Please Select..., Turkey (Türkiye)
View Trial Details