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

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

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.

Study Overview

• Status: Completed
• Conditions: Low-grade Inflammation; Increased Intestinal Permeability
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Active, only probiotics; Dietary supplement: Active, blend of berries and probiotics

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.	Dietary supplement: Placebo; Powder
Active Comparator: Active, only probiotics; Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste.	Dietary supplement: Active, only probiotics; Powder
Active Comparator: Active, blend of berries and probiotics; Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.	Dietary supplement: Active, blend of berries and probiotics; Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Probi AB
• Collaborators: Lund University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 4, 2015

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2014/3