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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: Lactobacillus; Dietary supplement: Bifidobacterium

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics_Lactobacillus; Intervention (2 weeks) with a strain of Lactobacillus	Dietary supplement: Lactobacillus; Intervention (2 weeks) with a strain of Lactobacillus; Other Names: 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 Names: Bifidobacterium infantis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
influence on immune system	to study the influence on systemic leukocytes and regulatory T cells	after 2 weeks intervention

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Study Director: Bengt Jeppson, MD, PhD, Region Skane

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): February 16, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 538/2005