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

Not Applicable

Completed

• Conditions: Low-grade Inflammation; Increased Intestinal Permeability
• Interventions: Dietary Supplement: Active, blend of berries and probiotics; Dietary Supplement: Active, only probiotics; Dietary Supplement: Placebo

• Registration Number: NCT02342496
• Lead Sponsor: Probi AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-18
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-21
• Primary Completion: 2015-12
• Study Completion: 2015-12-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active, blend of berries and probiotics	Active, blend of berries and probiotics	Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.
Active, only probiotics	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.
Placebo	Placebo	Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lund University; 🇸🇪 Malmö, Sweden