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

NCT02342496 | Completed

• 1 other identifier: 2014/3
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Low-grade Inflammation; Increased Intestinal Permeability

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Active, only probiotics

ACTIVE COMPARATOR

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

Active, blend of berries and probiotics

ACTIVE COMPARATOR

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

Dietary Supplement: Active, blend of berries and probiotics

Interventions

Placebo DIETARY_SUPPLEMENT

Powder

Placebo

Active, only probiotics DIETARY_SUPPLEMENT

Powder

Active, only probiotics

Active, blend of berries and probiotics DIETARY_SUPPLEMENT

Powder

Active, blend of berries and probiotics

Eligibility Criteria

• Age: 75 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>75 years
• CRP 2-10 mg/L
• Ability to fill in a study diary by him/herself

You may not qualify if:

• Currently on corticosteroid treatment
• Presence of chronic inflammatory disease

Sponsors & Collaborators

• Probi AB: lead
• Lund University: collaborator

Study Sites (1)

Lund University

Malmo, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38896223 DERIVED

MeSH Terms

Interventions

Exercise; Probiotics

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 21, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 4, 2015
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

SE (1)