Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

NCT ID: NCT01534572

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Probiotics_Lactobacillus

Intervention (2 weeks) with a strain of Lactobacillus

Group Type: EXPERIMENTAL

Lactobacillus

Intervention Type: DIETARY_SUPPLEMENT

Intervention (2 weeks) with a strain of Lactobacillus

Probiotics_Bifidobacterium

Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium.

Group Type: EXPERIMENTAL

Bifidobacterium

Intervention Type: DIETARY_SUPPLEMENT

Intervention (2 weeks) with a strain of Bifidobacterium

Interventions

Lactobacillus

Intervention (2 weeks) with a strain of Lactobacillus

Intervention Type: DIETARY_SUPPLEMENT

Bifidobacterium

Intervention (2 weeks) with a strain of Bifidobacterium

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lactobacillus plantarum; Bifidobacterium infantis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bengt Jeppson, MD, PhD

Role: STUDY_DIRECTOR

Region Skåne

References

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.

Reference Type: DERIVED

PMID: 35247974 (View on PubMed)

Other Identifiers

538/2005

Identifier Type: -

Identifier Source: org_study_id