Healthy Volunteers
Conditions
Keywords
Synbiotics, Intestinal permeability, Microbiota, Immune response
Brief summary
In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.
Interventions
DIETARY_SUPPLEMENTEcologic 825/scFOS
DIETARY_SUPPLEMENTPlacebo
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined * Age between 18 and 65 years * Body Mass Index (BMI) between 20 and 30 kilogram/m2
Exclusion criteria
* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing * Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study * Use of antibiotics in the 90 days prior to the study * Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator) * Pregnancy, lactation * Excessive alcohol consumption (\>20 alcoholic consumptions per week) * Smoking * Blood donation within 3 months before or after the study period * Self-admitted Human immunodeficiency virus-positive state * History of any side effects towards intake of pro- or prebiotic supplements of any kind
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sugar recovery in urine, as indicator of intestinal permeability | Baseline and after 2 weeks intervention |
Secondary
| Measure | Time frame |
|---|---|
| Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR) | Baseline and after 2 weeks intervention |
| Barcoded pyrosequencing of 16S rRNA genes of the microbiota | Baseline and after 2 weeks intervention |
| Biomarkers of immune modulation; plasma levels of Tumor necrosis factor alpha , Interleukin-1 beta, Interleukin-6, Interleukin-8, Interleukin-17, Monocyte chemoattractant protein-1 and Macrophage inflammatory protein-1a | Baseline and after 2 weeks intervention |
| 10 item gastrointestinal symptom diary | Baseline and after 2 weeks intervention |
| Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota | Baseline and after 2 weeks intervention |
| Metatranscriptomics of the microbiota | Baseline and after 2 weeks intervention |
Countries
Netherlands
Outcome results
None listed