NCT02018900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy-volunteers

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

December 9, 2013

Last Update Submit

December 22, 2014

Conditions

Healthy Volunteers

Keywords

SynbioticsIntestinal permeabilityMicrobiotaImmune response

Outcome Measures

Primary Outcomes (1)

  • Sugar recovery in urine, as indicator of intestinal permeability

    Baseline and after 2 weeks intervention

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Ecologic 825/scFOS

EXPERIMENTAL

Ecologic 825/scFOS

Dietary Supplement: Ecologic 825/scFOS

Interventions

Ecologic 825/scFOSDIETARY_SUPPLEMENT
Ecologic 825/scFOS
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

  • An R, Wilms E, Gerritsen J, Kim HK, Perez CS, Besseling-van der Vaart I, Jonkers DMAE, Rijkers GT, de Vos WM, Masclee AAM, Zoetendal EG, Troost FJ, Smidt H. Spatio-temporal dynamics of the human small intestinal microbiome and its response to a synbiotic. Gut Microbes. 2024 Jan-Dec;16(1):2350173. doi: 10.1080/19490976.2024.2350173. Epub 2024 May 13.

    PMID: 38738780DERIVED

Study Officials

  • A.A.M. Masclee, Professor

    Department of Internal Medicine, Division of Gastroenterology-Hepatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 23, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

NL(1)