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Completed

NCT Number: NCT02018900

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ecologic 825/scFOS

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Sugar recovery in urine, as indicator of intestinal permeability

    Time frame: Baseline and after 2 weeks intervention

Secondary outcomes

  1. 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

    Time frame: Baseline and after 2 weeks intervention

  2. Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)

    Time frame: Baseline and after 2 weeks intervention

  3. Barcoded pyrosequencing of 16S rRNA genes of the microbiota

    Time frame: Baseline and after 2 weeks intervention

  4. Metatranscriptomics of the microbiota

    Time frame: Baseline and after 2 weeks intervention

  5. 10 item gastrointestinal symptom diary

    Time frame: Baseline and after 2 weeks intervention

  6. Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota

    Time frame: Baseline and after 2 weeks intervention

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: CRIB

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2013
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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