Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

Inflammation Clinical Trial

Official title:

Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534572
• Other study ID #: 538/2005
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: February 15, 2012
• Start date: January 2006
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Lactobacillus
Intervention (2 weeks) with a strain of Lactobacillus
• Bifidobacterium
Intervention (2 weeks) with a strain of Bifidobacterium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactivity of rectal mucosa	to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics	after 2 weeks intervention	No
Secondary	influence on immune system	to study the influence on systemic leukocytes and regulatory T cells	after 2 weeks intervention	No