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

NCT ID: NCT02342496

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-04

Brief Summary

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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

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Conditions

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Low-grade Inflammation Increased Intestinal Permeability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Powder

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.

Group Type ACTIVE_COMPARATOR

Active, only probiotics

Intervention Type DIETARY_SUPPLEMENT

Powder

Active, blend of berries and probiotics

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

Group Type ACTIVE_COMPARATOR

Active, blend of berries and probiotics

Intervention Type DIETARY_SUPPLEMENT

Powder

Interventions

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Placebo

Powder

Intervention Type DIETARY_SUPPLEMENT

Active, only probiotics

Powder

Intervention Type DIETARY_SUPPLEMENT

Active, blend of berries and probiotics

Powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lund University

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Lazou-Ahren I, Bjorklund M, Molin G, Xu J, Onning G, Elmstahl S, Jeppsson B. Probiotic-Reduced Inflammaging in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3429-3439. doi: 10.1007/s12602-024-10310-7. Epub 2024 Jun 19.

Reference Type DERIVED
PMID: 38896223 (View on PubMed)

Other Identifiers

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2014/3

Identifier Type: -

Identifier Source: org_study_id

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