Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01534572
First received: February 13, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Inflammation
Dietary Supplement: Lactobacillus
Dietary Supplement: Bifidobacterium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Reactivity of rectal mucosa [ Time Frame: after 2 weeks intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 2 weeks intervention ] [ Designated as safety issue: No ]
    to study the influence on systemic leukocytes and regulatory T cells


Enrollment: 12
Study Start Date: January 2006
Study Completion Date: February 2012
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics_Lactobacillus
Intervention (2 weeks) with a strain of Lactobacillus
Dietary Supplement: Lactobacillus
Intervention (2 weeks) with a strain of Lactobacillus
Other Name: Lactobacillus plantarum
Experimental: Probiotics_Bifidobacterium
Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.
Dietary Supplement: Bifidobacterium
Intervention (2 weeks) with a strain of Bifidobacterium
Other Name: Bifidobacterium infantis

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534572

Sponsors and Collaborators
Region Skane
Investigators
Study Director: Bengt Jeppson, MD, PhD Region Skåne
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01534572     History of Changes
Other Study ID Numbers: 538/2005
Study First Received: February 13, 2012
Last Updated: February 15, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014