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Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactobacillus
Bifidobacterium
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-80 years old,
  • Able to understand oral and written information,
  • Informed consent

Exclusion Criteria:

  • Ongoing immune suppressive treatment, incl. cortisone,
  • Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
  • History of inflammatory bowel disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Probiotics_Lactobacillus

    Probiotics_Bifidobacterium

    Arm Description

    Intervention (2 weeks) with a strain of Lactobacillus

    Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.

    Outcomes

    Primary Outcome Measures

    Reactivity of rectal mucosa
    to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics

    Secondary Outcome Measures

    influence on immune system
    to study the influence on systemic leukocytes and regulatory T cells

    Full Information

    First Posted
    February 13, 2012
    Last Updated
    February 15, 2012
    Sponsor
    Region Skane
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01534572
    Brief Title
    Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
    Official Title
    Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Skane

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body. The hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics_Lactobacillus
    Arm Type
    Experimental
    Arm Description
    Intervention (2 weeks) with a strain of Lactobacillus
    Arm Title
    Probiotics_Bifidobacterium
    Arm Type
    Experimental
    Arm Description
    Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus
    Other Intervention Name(s)
    Lactobacillus plantarum
    Intervention Description
    Intervention (2 weeks) with a strain of Lactobacillus
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bifidobacterium
    Other Intervention Name(s)
    Bifidobacterium infantis
    Intervention Description
    Intervention (2 weeks) with a strain of Bifidobacterium
    Primary Outcome Measure Information:
    Title
    Reactivity of rectal mucosa
    Description
    to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics
    Time Frame
    after 2 weeks intervention
    Secondary Outcome Measure Information:
    Title
    influence on immune system
    Description
    to study the influence on systemic leukocytes and regulatory T cells
    Time Frame
    after 2 weeks intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-80 years old, Able to understand oral and written information, Informed consent Exclusion Criteria: Ongoing immune suppressive treatment, incl. cortisone, Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks, History of inflammatory bowel disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bengt Jeppson, MD, PhD
    Organizational Affiliation
    Region Skåne
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35247974
    Citation
    Stene C, Rome A, Palmquist I, Linninge C, Molin G, Ahrne S, Johnson LB, Jeppsson B. Administration of probiotics to healthy volunteers: effects on reactivity of intestinal mucosa and systemic leukocytes. BMC Gastroenterol. 2022 Mar 5;22(1):100. doi: 10.1186/s12876-022-02185-1.
    Results Reference
    derived

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    Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

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