Clinical trial NCT02018900: The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation
Official title: The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Synbiotics
Intestinal permeability
Microbiota
Immune response
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sugar recovery in urine, as indicator of intestinal permeability
timeFrame: Baseline and after 2 weeks intervention
Secondary outcomes:
measure: 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
timeFrame: Baseline and after 2 weeks intervention
measure: Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)
timeFrame: Baseline and after 2 weeks intervention
measure: Barcoded pyrosequencing of 16S rRNA genes of the microbiota
timeFrame: Baseline and after 2 weeks intervention
measure: Metatranscriptomics of the microbiota
timeFrame: Baseline and after 2 weeks intervention
measure: 10 item gastrointestinal symptom diary
timeFrame: Baseline and after 2 weeks intervention
measure: Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota
timeFrame: Baseline and after 2 weeks intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology
name: A.A.M. Masclee, Professor
role: PRINCIPAL_INVESTIGATOR
References: