Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly

Low-grade Inflammation Clinical Trial

Official title:

Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342496
• Other study ID #: 2014/3
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: April 12, 2018
• Start date: January 2015
• Est. completion date: December 4, 2015

Study information

• Verified date: April 2018
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 4, 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age >75 years

• CRP 2-10 mg/L

• Ability to fill in a study diary by him/herself

Exclusion Criteria:

• Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.

• Currently on corticosteroid treatment

• Presence of chronic inflammatory disease

Related Conditions & MeSH terms

• Increased Intestinal Permeability
• Inflammation
• Low-grade Inflammation

Intervention

Dietary Supplement:
• Placebo
Powder
• Active, only probiotics
Powder
• Active, blend of berries and probiotics
Powder

Locations

Country	Name	City	State
Sweden	Lund University	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Probi AB	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples		All blood markers analysed in the study will be measured at start, before the onset of intervention and 4 weeks later at the end of intervention.