Effect of Encapsulated Vs Free Probiotic on Brain Function

NCT05801042 | Completed

• 1 other identifier: AnaBio
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is associated with changes in a wide variety of brain networks, including the default mode, saliency attention, and visual networks. Furthermore, current research suggests that a relationship exists between functional connectivity at rest and cognition. Lactocaseibacillus rhamnosus is an ideal strain for the intervention, as it has been show to affect the gut-brain axis, brain function, and behavior. Therefore, the investigators plan to assess resting state functional magnetic resonance imaging (fMRI) to compare changes in brain connectivity between the groups receiving the encapsulate and non-encapsulated Lactocaseibacillus rhamnosus supplements.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)

  corrected for baseline

  6 weeks

Secondary Outcomes (16)

• Levels of inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain using MR spectroscopy (MRS)

  6 weeks

• Cognitive function assessment using the trail making test (TMT)

  6 weeks

• Cognitive function assessment using digit symbol substitution test (TMT)

  6 weeks

• Cognitive function assessment using letter digit substitution test

  6 weeks

• Cognitive function assessment using letter comparison test

  6 weeks

Other Outcomes (18)

• Brain stem functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)

  6 weeks

• Brain structure measured by magnetic resonance imaging (fMRI)

  6 weeks

• Characterisation of probiotic bacteria in faecal samples using flow cytometry

  6 weeks

Study Arms (3)

Encapsulated probiotic

EXPERIMENTAL

Dietary Supplement: Encapsulated Lactocaseibacillus rhamnosus

Non-encapsulated probiotic

ACTIVE COMPARATOR

Dietary Supplement: Non-encapsulated Lactocaseibacillus rhamnosus

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin

Interventions

Maltodextrin DIETARY_SUPPLEMENT

Placebo product

Placebo

Encapsulated Lactocaseibacillus rhamnosus DIETARY_SUPPLEMENT

Probiotic product

Encapsulated probiotic

Non-encapsulated Lactocaseibacillus rhamnosus DIETARY_SUPPLEMENT

Probiotic product

Non-encapsulated probiotic

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study-related procedure
• Age 60-80 years-old
• Normal weight at the screening defined as BMI range 18.5-31.9
• Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages)
• Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study

You may not qualify if:

• Diagnosis of type 1 and/or type 2 diabetes
• Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
• Immobile (defined as the inability to participate in all study-related procedures)
• History of complicated gastrointestinal surgery
• Diagnosed inflammatory bowel disease (IBD)
• Current diagnosis of psychiatric disease/s or syndromes
• Current diagnosis of neurodegenerative disease
• Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months
• Consumption of any NSAID within 7 days of study start
• Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, irritable bowel syndrome (IBS), IBD) or in any other way with the outcome of the study, as decided by the principle investigator's discretion
• Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use
• Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
• After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis
• Cerebral bleeding or history of cerebral bleeding
• Claustrophobia

Sponsors & Collaborators

• Robert Brummer: lead

Study Sites (1)

Örebro University

Örebro, Örebro County, 70182, Sweden

Location

Related Publications (1)

• Rode J, Hutchinson AN, Chatzopoulou MS, Bleiel SB, Gebresenbet RF, Andersson L, Persson J, Daillere R, Beitz B, Ben Abdallah B, Tingo L, Bergh C, Brummer RJ. Micro-encapsulation differentially impacts probiotic effects on brain structure and function in an elderly population - A randomised placebo-controlled trial. Brain Behav Immun. 2025 Nov;130:106113. doi: 10.1016/j.bbi.2025.106113. Epub 2025 Sep 19.

  PMID: 40976401 DERIVED

MeSH Terms

Interventions

maltodextrin

Study Officials

• Robert JM Brummer, MD PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: April 6, 2023
• Study Start: February 7, 2023
• Primary Completion: November 10, 2023
• Study Completion: September 30, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)