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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 1 | Active Comparator | Fresh fermented dairy drink containing yoghurt ferments consumed as follows: one bottle (100g) OD for 14 consecutive days |
|
| Probiotic 2 | Active Comparator | Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) OD for 14 consecutive days |
|
| Placebo | Placebo Comparator | Acidified dairy drink without ferments consumed as follows: one bottle (100g) OD for 14 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic 1 | Dietary Supplement | Fresh fermented dairy drink containing yoghurt ferments |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Temporal microbial composition and activity in the small intestine in ileal effluent | 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. | 2 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Small intestinal permeability by a multi sugar test (urinary recovery of test sugars) | 2 weeks intervention | |
| Gene transcription response in blood by transcriptome patterns. | Transcriptome patterns will be determined in peripheral blood mononuclear cells obtained from blood samples from the participating ileostoma patients |
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Inclusion Criteria:
• Ileostomy installed at least 3 years prior to participation
Exclusion Criteria:
• History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Fred Troost, PhD | Maastricht University Medical Center (MUMC+) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36879297 | Derived | Zaccaria E, Klaassen T, Alleleyn AME, Boekhorst J, Smokvina T, Kleerebezem M, Troost FJ. Endogenous small intestinal microbiome determinants of transient colonisation efficiency by bacteria from fermented dairy products: a randomised controlled trial. Microbiome. 2023 Mar 7;11(1):43. doi: 10.1186/s40168-023-01491-4. |
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| Probiotic 2 |
| Dietary Supplement |
Fresh fermented dairy drink containing probiotic strain |
|
| Placebo | Dietary Supplement | Acidified dairy drink without ferments |
|
| 2 weeks intervention |
| The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status | A panel of biomarkers will be determined in peripheral blood obtained at the start and end of the intervention periods | 2 weeks intervention |
| The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo | Peripheral whole blood immune responsiveness towards a subset of bacterial immune-stimuli will be assessed using the standardized truculture system | 2 weeks intervention |
| Morning urine metabolome profiles | 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. | 2 weeks intervention |
| Peripheral blood metabolome profiles | 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. | 2 weeks intervention |
| The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates) | 2 weeks intervention |
| Short chain fatty acid profiles in ileal effluent | 2 weeks intervention |
| Number of participants with Gastrointestinal symptoms by Visual Analogue Scales | 2 weeks intervention |
| Occurrence and severity of treatment related adverse events | 2 weeks intervention |