Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Dietary Supplement: Lactobacillus; Dietary Supplement: Bifidobacterium

• Registration Number: NCT01534572
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-03
• Status Verified: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Study First Posted: 2012-02-16
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics_Lactobacillus	Lactobacillus	Intervention (2 weeks) with a strain of Lactobacillus
Probiotics_Bifidobacterium	Bifidobacterium	Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.

Primary Outcome Measures

Name	Time	Method
Reactivity of rectal mucosa	after 2 weeks intervention	to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics

Secondary Outcome Measures

Name	Time	Method
influence on immune system	after 2 weeks intervention	to study the influence on systemic leukocytes and regulatory T cells