Healthy Volunteers, gastrointestinal diseases, diabetes Healthy volunteers, gastrointestinal diseases, diabetes
Conditions
Interventions
Not applicable - no study product will be used.
Sponsors
Danone Global research & Innovation center
Eligibility
Age
No minimum to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria will depend on the specific study request and the required study population, but will include at least the following: - Age (in years/months/weeks) of the intended study population - Health condition of the intended study population (i.e. being in a good health condition (self- or parent-reported)/or having a certain disease/diagnosis (self- or parentreported and/or confirmed by physician)) - Willing and able to collect faecal sample(s) and to deliver them personally or by the subject’s parent in a cooler bag to the site within 24 hours after collection. - Dutch speaking and reading, to communicate with the site staff and to comply with the requirements of the entire study. - Signed (written) informed consent from participant, aged = 16 years - If applicable (in case participants are between 12-16 years old), signed informed assent from participant - If applicable (in case participants are younger than 16 years old), signed informed consent from both parents and/or legally acceptable representatives of the participants, both aged = 18 years.
Exclusion criteria
Exclusion criteria: Exclusion criteria will depend on the specific study request and the required study population needed, but will include at least the following: - Systemic antibiotic use at least 8 weeks prior to study enrolment (unless antibiotic users is the study population of interest). - Having chronic disorders like irritable bowel syndrome (IBS) affecting the gut (unless such patients or infants are the study population of interest) - Current or intended participation in a clinical study involving investigational or marketed products. - Employees and/or children/family members or direct relatives of employees of Danone Global Research & Innovation Center or the participating sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory outcome measures of the preclinical in vitro experiments in these studies are as follows:Change in composition and function of the gut microbiota by biotics (nutrients) in vitro, measured with metagenomics.Production of metabolites by (nutrients) in vitro, including:Short-chain fatty acidsLactateAmmoniaOther metabolites can also be measured using techniques such as metabolomics, proteomics, and transcriptomics.Colonization by probiotics to assess whether different probiotic strains can adhere to the gastrointestinal mucosa, enabling them to exert their beneficial effects.Fermentation products from the in vitro experiments (in vitro faecal slurry fermentation models) can further be used to assess other health parameters, such as:Gut barrier functionInflammatory markersMuscle protein synthesis and other muscle functions, such as mitochondrial functionInhibition of pathogens | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary parameters as all are explorative parameters. | — |
Countries
Netherlands
Contacts
Public ContactETHC Smeets
Danone Global research & Innovation center
Outcome results
None listed