Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encapsulated probiotic | Experimental |
| |
| Non-encapsulated probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | Placebo product |
| |
| Encapsulated Lactocaseibacillus rhamnosus |
| Measure | Description | Time Frame |
|---|---|---|
| Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | corrected for baseline | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain using MR spectroscopy (MRS) | corrected for baseline | 6 weeks |
| Cognitive function assessment using the trail making test (TMT) |
| Measure | Description | Time Frame |
|---|---|---|
| Brain stem functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | corrected for baseline | 6 weeks |
| Brain structure measured by magnetic resonance imaging (fMRI) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert JM Brummer, MD PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | Örebro County | 70182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40976401 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
Probiotic product |
|
| Non-encapsulated Lactocaseibacillus rhamnosus | Dietary Supplement | Probiotic product |
|
corrected for baseline, scale 0-400 seconds and number of errors, higher scores indicate worse cognition
| 6 weeks |
| Cognitive function assessment using digit symbol substitution test (TMT) | corrected for baseline, scale 0-93 points, higher scores indicate better cognition | 6 weeks |
| Cognitive function assessment using letter digit substitution test | corrected for baseline, scale 0-135 points, higher scores indicate better cognition | 6 weeks |
| Cognitive function assessment using letter comparison test | corrected for baseline, scale 0-42 points, higher scores indicate better cognition | 6 weeks |
| Cognitive function assessment using Rey-Auditory Verbal Learning Test | corrected for baseline, scale 0-120 points, higher scores indicate better cognition | 6 weeks |
| Cognitive function assessment using N-back task | corrected for baseline, higher scores indicate better cognition | 6 weeks |
| Cognitive function assessment using Face-Name Paired Associate Task (FNPA) | corrected for baseline, higher scores indicate better cognition | 6 weeks |
| 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 | 6 weeks |
| 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 | 3 weeks |
| Levels of metabolic blood markers (blood fats) | corrected for baseline, unit of measurement concentration given as mg/ml | 6 weeks |
| Levels of metabolic blood markers (blood fats) | corrected for baseline, unit of measurement concentration given as mg/ml | 3 weeks |
| Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin) | corrected for baseline, unit of measurement concentration given as mg/ml | 6 weeks |
| Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin) | corrected for baseline, unit of measurement concentration given as mg/ml | 3 weeks |
| Characterisation of lymphocyte subpopulations using flow cytometry | corrected for baseline | 6 weeks |
| Faecal samples for evaluation of gut microbiota composition via next-generation sequencing (NGS) | corrected for baseline | 6 weeks |
corrected for baseline
| 6 weeks |
| Characterisation of probiotic bacteria in faecal samples using flow cytometry | corrected for baseline | 6 weeks |
| Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS) | corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms | 3 weeks |
| Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS) | corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms | 6 weeks |
| Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI) | corrected for baseline, scale 0-21, higher score indicates worse sleep | 3 weeks |
| Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI) | corrected for baseline, scale 0-21, higher score indicates worse sleep | 6 weeks |
| Assessment of psychological health using Perceived Stress Scale (PSS) | corrected for baseline, scale 0-40, higher score indicates more perceived stress | 3 weeks |
| Assessment of psychological health using Perceived Stress Scale (PSS) | corrected for baseline, scale 0-40, higher score indicates more perceived stress | 6 weeks |
| Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS) | corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms | 3 weeks |
| Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS) | corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms | 6 weeks |
| Cognitive function assessment using the Montreal Cognitive Assessment (MoCA) | corrected for baseline, scale 0-30 points, higher scores indicate better cognition | 6 weeks |
| Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI) | corrected for baseline | 10-12 weeks |
| Assessment of psychological health using Hospital Anxiety and Depression Scale (HADS) | corrected for baseline, scale 0-42, higher score indicates worse anxiety and depression symptoms | 10-12 weeks |
| Assessment of psychological health using Pittsburgh Sleep Quality Index (PSQI) | corrected for baseline, scale 0-21, higher score indicates worse sleep | 10-12 weeks |
| Assessment of psychological health using Perceived Stress Scale (PSS) | corrected for baseline, scale 0-40, higher score indicates more perceived stress | 10-12 weeks |
| Assessment of gastrointestinal health using Gastrointestinal Symptoms Rating Scale (GSRS) | corrected for baseline, scale 15-105, higher score indicates more gastrointestinal symptoms | 10-12 weeks |
| Brain structure measured by magnetic resonance imaging (fMRI) | corrected for baseline | 10-12 weeks |