Effect of Encapsulated Vs Free Probiotic on Brain Function

NCT ID: NCT05801042

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Encapsulated probiotic

Group Type: EXPERIMENTAL

Encapsulated Lactocaseibacillus rhamnosus

Intervention Type: DIETARY_SUPPLEMENT

Probiotic product

Non-encapsulated probiotic

Group Type: ACTIVE_COMPARATOR

Non-encapsulated Lactocaseibacillus rhamnosus

Intervention Type: DIETARY_SUPPLEMENT

Probiotic product

Placebo

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Placebo product

Interventions

Maltodextrin

Placebo product

Intervention Type: DIETARY_SUPPLEMENT

Encapsulated Lactocaseibacillus rhamnosus

Probiotic product

Intervention Type: DIETARY_SUPPLEMENT

Non-encapsulated Lactocaseibacillus rhamnosus

Probiotic product

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Brummer

OTHER

Sponsor Role: lead

Responsible Party

Robert Brummer

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert JM Brummer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Örebro University

Örebro, Örebro County, Sweden

Countries

Sweden

References

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 Sep 19;130:106113. doi: 10.1016/j.bbi.2025.106113. Online ahead of print.

Reference Type: DERIVED

PMID: 40976401 (View on PubMed)

Other Identifiers

AnaBio

Identifier Type: -

Identifier Source: org_study_id