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

Healthy Volunteers Clinical Trial

— CRIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018900
• Other study ID #: 13-3-016
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2013
• Last updated: December 22, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Ecologic 825/scFOS

• Placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sugar recovery in urine, as indicator of intestinal permeability		Baseline and after 2 weeks intervention	No
Secondary	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	No
Secondary	Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)		Baseline and after 2 weeks intervention	No
Secondary	Barcoded pyrosequencing of 16S rRNA genes of the microbiota		Baseline and after 2 weeks intervention	No
Secondary	Metatranscriptomics of the microbiota		Baseline and after 2 weeks intervention	No
Secondary	10 item gastrointestinal symptom diary		Baseline and after 2 weeks intervention	Yes
Secondary	Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota		Baseline and after 2 weeks intervention	No