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

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ecologic 825/scFOS

• Registration Number: NCT02018900
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Ecologic 825/scFOS	Ecologic 825/scFOS	Ecologic 825/scFOS

Primary Outcome Measures

Name	Time	Method
Sugar recovery in urine, as indicator of intestinal permeability	Baseline and after 2 weeks intervention

Secondary Outcome Measures

Name	Time	Method
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
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
Metatranscriptomics of the microbiota	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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands