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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ecologic 825/scFOS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: Ecologic 825/scFOS	Dietary supplement: Ecologic 825/scFOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sugar recovery in urine, as indicator of intestinal permeability	Baseline and after 2 weeks intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 22, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Microbiota; Immune response; Intestinal permeability; Synbiotics
• Other Study ID Numbers: 13-3-016