The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation (CRIB)

Maastricht University Medical Centre (MUMC)

Status and phase

Completed

Phase 4

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Ecologic 825/scFOS

Study type

Interventional

Funder types

Other

Identifiers

NCT02018900

13-3-016

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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