Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 16, 2012
CompletedFebruary 16, 2012
February 1, 2012
2 months
February 13, 2012
February 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
influence on immune system
after 2 weeks intervention
Study Arms (2)
Probiotics_Lactobacillus
EXPERIMENTALIntervention (2 weeks) with a strain of Lactobacillus
Probiotics_Bifidobacterium
EXPERIMENTALIntervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.
Interventions
Intervention (2 weeks) with a strain of Lactobacillus
Intervention (2 weeks) with a strain of Bifidobacterium
Eligibility Criteria
You may qualify if:
- years old,
- Able to understand oral and written information,
- Informed consent
You may not qualify if:
- Ongoing immune suppressive treatment, incl. cortisone,
- Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
- History of inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Related Publications (1)
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.
PMID: 35247974DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bengt Jeppson, MD, PhD
Region Skåne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2012
First Posted
February 16, 2012
Study Start
January 1, 2006
Primary Completion
March 1, 2006
Study Completion
February 1, 2012
Last Updated
February 16, 2012
Record last verified: 2012-02