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

Primary Purpose

Low-grade Inflammation, Increased Intestinal Permeability

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Placebo
Active, only probiotics
Active, blend of berries and probiotics
Sponsored by
Probi AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-grade Inflammation

Eligibility Criteria

75 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Active, only probiotics

Active, blend of berries and probiotics

Arm Description

Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.

Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste.

Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.

Outcomes

Primary Outcome Measures

Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples

Secondary Outcome Measures

Full Information

First Posted
December 18, 2014
Last Updated
April 12, 2018
Sponsor
Probi AB
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02342496
Brief Title
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly
Official Title
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
Collaborators
Lund University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Inflammation, Increased Intestinal Permeability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.
Arm Title
Active, only probiotics
Arm Type
Active Comparator
Arm Description
Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste.
Arm Title
Active, blend of berries and probiotics
Arm Type
Active Comparator
Arm Description
Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Active, only probiotics
Intervention Description
Powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Active, blend of berries and probiotics
Intervention Description
Powder
Primary Outcome Measure Information:
Title
Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lund University
City
Malmö
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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