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AgingNCT05801042

Effect of Encapsulated Vs Free Probiotic on Brain Function

A study testing Maltodextrin, Encapsulated Lactocaseibacillus rhamnosus and Non-encapsulated Lactocaseibacillus rhamnosus in people with Aging, run by Robert Brummer at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Maltodextrin, Encapsulated Lactocaseibacillus rhamnosus and Non-encapsulated Lactocaseibacillus rhamnosus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
1 siteSweden
Study dates
7 Feb 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • Current diagnosis of neurodegenerative disease
  • Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
  • 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
  • Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
  • 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
  • In operated apparatus (e.g., pacemaker), as it interferes with MR imaging
  • Aneurysm clips in the head
  • Shunts in the head
  • Grenade-splinter or metal-splinter in the body (e.g., eyes)
  • Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
  • Comprehensive tooth-implants or prosthesis
  • Operated in the head
  • Operated in the heart
  • Swallowed a video-capsule, which may still be in the GI tract
  • Left-handed

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Örebro University

    Örebro, Örebro County, 70182

Other trials in Sweden

About this study

Official title: Comparing the Efficacy of Micro-encapsulated Lactocaseibacillus Rhamnosus Vs Free Probiotic in Powder to Affect Brain Connectivity

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
Being tested
Maltodextrin, Encapsulated Lactocaseibacillus rhamnosus, Non-encapsulated Lactocaseibacillus rhamnosus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaltodextrinDietary supplement

    Placebo product

  • Encapsulated Lactocaseibacillus rhamnosusDietary supplement

    Probiotic product

  • Non-encapsulated Lactocaseibacillus rhamnosusDietary supplement

    Probiotic product

Study groups in NCT05801042
Study groupRoleWhat they receive
Encapsulated probioticExperimentalNot described
Receives: Dietary Supplement: Encapsulated Lactocaseibacillus rhamnosus
Non-encapsulated probioticActive comparatorNot described
Receives: Dietary Supplement: Non-encapsulated Lactocaseibacillus rhamnosus
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    corrected for baseline

    Measured: 6 weeks

Secondary outcomes (16)

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

    corrected for baseline

    Measured: 6 weeks

  2. Cognitive function assessment using the trail making test (TMT)

    corrected for baseline, scale 0-400 seconds and number of errors, higher scores indicate worse cognition

    Measured: 6 weeks

  3. Cognitive function assessment using digit symbol substitution test (TMT)

    corrected for baseline, scale 0-93 points, higher scores indicate better cognition

    Measured: 6 weeks

  4. Cognitive function assessment using letter digit substitution test

    corrected for baseline, scale 0-135 points, higher scores indicate better cognition

    Measured: 6 weeks

  5. Cognitive function assessment using letter comparison test

    corrected for baseline, scale 0-42 points, higher scores indicate better cognition

    Measured: 6 weeks

  6. Cognitive function assessment using Rey-Auditory Verbal Learning Test

    corrected for baseline, scale 0-120 points, higher scores indicate better cognition

    Measured: 6 weeks

  7. Cognitive function assessment using N-back task

    corrected for baseline, higher scores indicate better cognition

    Measured: 6 weeks

  8. Cognitive function assessment using Face-Name Paired Associate Task (FNPA)

    corrected for baseline, higher scores indicate better cognition

    Measured: 6 weeks

  9. Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 6 weeks

  10. Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 3 weeks

  11. Levels of metabolic blood markers (blood fats)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 6 weeks

  12. Levels of metabolic blood markers (blood fats)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 3 weeks

  13. Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 6 weeks

  14. Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin)

    corrected for baseline, unit of measurement concentration given as mg/ml

    Measured: 3 weeks

  15. Characterisation of lymphocyte subpopulations using flow cytometry

    corrected for baseline

    Measured: 6 weeks

  16. Faecal samples for evaluation of gut microbiota composition via next-generation sequencing (NGS)

    corrected for baseline

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start7 Feb 2023
  3. Primary completion10 Nov 2023
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05801042
Sponsor's protocol ID
AnaBio
Status last verified
Oct 2024
First submitted
10 Feb 2023
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hutchinson AN, Brummer RJ, Rode J. Probiotic effects on brain health are both transient and sustained for several weeks after discontinuation: a randomised controlled trial. Commun Med (Lond). 2026 Jul 28;6(1):418. doi: 10.1038/s43856-026-01800-6.

    PubMed 42521749

  • 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.

    PubMed 40976401

Questions about this trial

What is this clinical trial studying?

A study testing Maltodextrin, Encapsulated Lactocaseibacillus rhamnosus and Non-encapsulated Lactocaseibacillus rhamnosus in people with Aging, run by Robert Brummer at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05801042, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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