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OpenTrials
Completed

NCT Number: NCT01534572

Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lactobacillus

Dietary Supplement

Intervention (2 weeks) with a strain of Lactobacillus

Other names: Lactobacillus plantarum

Bifidobacterium

Dietary Supplement

Intervention (2 weeks) with a strain of Bifidobacterium

Other names: Bifidobacterium infantis

Primary outcomes

  1. Reactivity of rectal mucosa

    Time frame: after 2 weeks intervention

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

Secondary outcomes

  1. influence on immune system

    Time frame: after 2 weeks intervention

    to study the influence on systemic leukocytes and regulatory T cells

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Feb 16, 2012

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.

Published trials that share one or more normalized conditions with this study.