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Completed

NCT Number: NCT02342496

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.

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Key information

Conditions

Low-grade Inflammation Increased Intestinal Permeability

Age range

75 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University

Malmö, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Powder

Active, only probiotics

Dietary Supplement

Powder

Active, blend of berries and probiotics

Dietary Supplement

Powder

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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