Effect of Encapsulated Vs Free Probiotic on Brain Function

Robert Brummer

Status: Completed

Conditions: Aging

Treatments: Dietary Supplement: Non-encapsulated Lactocaseibacillus rhamnosus; Dietary Supplement: Encapsulated Lactocaseibacillus rhamnosus; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT05801042

AnaBio

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Diagnosis of type 1 and/or type 2 diabetes
2. Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
3. Immobile (defined as the inability to participate in all study-related procedures)
4. History of complicated gastrointestinal surgery
5. Diagnosed inflammatory bowel disease (IBD)
6. Current diagnosis of psychiatric disease/s or syndromes
7. Current diagnosis of neurodegenerative disease
8. Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
9. Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months
10. Consumption of any NSAID within 7 days of study start
11. 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
12. Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use
13. Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
14. 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.)
15. After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis
16. Cerebral bleeding or history of cerebral bleeding
17. Claustrophobia
18. In operated apparatus (e.g., pacemaker), as it interferes with MR imaging
19. Aneurysm clips in the head
20. Shunts in the head
21. Grenade-splinter or metal-splinter in the body (e.g., eyes)
22. Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
23. Comprehensive tooth-implants or prosthesis
24. Operated in the head
25. Operated in the heart
26. Swallowed a video-capsule, which may still be in the GI tract
27. Left-handed

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

Encapsulated probiotic

Experimental group

Treatment:

Dietary Supplement: Encapsulated Lactocaseibacillus rhamnosus

Non-encapsulated probiotic

Active Comparator group

Treatment:

Dietary Supplement: Non-encapsulated Lactocaseibacillus rhamnosus

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin