Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX, Netherlands
NCT Number: NCT02920294
To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229 HX, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fresh fermented dairy drink containing yoghurt ferments
Fresh fermented dairy drink containing probiotic strain
Acidified dairy drink without ferments
Time frame: 2 weeks intervention
The microbiome activity will be determined as a function of the diet by double strand cDNA production and random sequencing of mRNA enriched fractions of total effluent RNA obtained from the effluent samples at the start and end of each intervention period.
Time frame: 2 weeks intervention
Time frame: 2 weeks intervention
Transcriptome patterns will be determined in peripheral blood mononuclear cells obtained from blood samples from the participating ileostoma patients
Time frame: 2 weeks intervention
A panel of biomarkers will be determined in peripheral blood obtained at the start and end of the intervention periods
Time frame: 2 weeks intervention
Peripheral whole blood immune responsiveness towards a subset of bacterial immune-stimuli will be assessed using the standardized truculture system
Time frame: 2 weeks intervention
The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.
Time frame: 2 weeks intervention
The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.
Time frame: 2 weeks intervention
Time frame: 2 weeks intervention
Time frame: 2 weeks intervention
Time frame: 2 weeks intervention
Maastricht University Medical Center
Other
Modulation of Small Intestinal Microbial Composition and Activity,Systemic Immune Adaptation and Blood Transcriptional Changes Induced by 2-wks Consumption With 2 Fermented Milk Products;a Randomized,Exploratory,Cross-over,Double Blind,Controlled Study in Ileostomy Patients
Acronym: INSIDE
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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.
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