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

NCT ID: NCT02018900

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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Synbiotics Intestinal permeability Microbiota Immune response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Ecologic 825/scFOS

Ecologic 825/scFOS

Group Type EXPERIMENTAL

Ecologic 825/scFOS

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ecologic 825/scFOS

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A.A.M. Masclee, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Division of Gastroenterology-Hepatology

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 38738780 (View on PubMed)

Other Identifiers

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13-3-016

Identifier Type: -

Identifier Source: org_study_id