Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03478527
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-01-26
Brief Title:
Probiotics Brain Structure and Psychological Variables
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Effects of Probiotic Bacteria on Brain Structure and Function and on Psychological Variables
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProBrain01
Brief Summary:
Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota immunological and hormonal responses brain function brain structure as well as resulting behavioral manifestations such as cognitive functions and mental illness Probiotics are living micro-organisms that change the composition of the gut microbiota and hypothetically have a positive effect on the hosts general health and well-being Probiotic bacteria naturally occur in foods such as Sauerkraut olives and dark chocolate and are currently also added to industrial products such as yogurt
Regarding the effect of probiotics on brain structure and function animal studies have shown that the administration of probiotics in mice and rats was linked to neurogenesis in the hippocampus and an improvement of associated cognitive functions The majority of these studies applied probiotics for 4 weeks The substances used in these studies were often composed of several bacterial strains suggesting that the neurogenic effect may not be reducible to a specific type of probiotic bacteria
Probiotics seem to be effective in improving memory abilities including spatial and non-spatial memory both in rodents and humans Moreover specifically regarding the beneficial effect of probiotics on anxiety depression and stress preliminary evidence in humans is compelling However methodologically sound randomized-controlled trial RCT blind studies are still lacking
To sum up the present study is going to be the first RCT with human participants that investigates structural and functional changes of the hippocampus through probiotic bacteria using Magnet Resonance Imaging MRI In addition the study aims at advancing research in the field by investigating the effects of probiotics on a broad spectrum of cognitive functions particularly those associated with hippocampal activity eg spatial memory verbal memory Furthermore effects on several types of mental illness eg anxiety depression stress will be studied Potential translatory mechanisms that may promote the aforementioned effects will be examined ie changes in immunological parameters brain derived neurotrophic factor BDNF and oxytocin
Regarding the effect of probiotics on brain structure and function animal studies have shown that the administration of probiotics in mice and rats was linked to neurogenesis in the hippocampus and an improvement of associated cognitive functions The majority of these studies applied probiotics for 4 weeks The substances used in these studies were often composed of several bacterial strains suggesting that the neurogenic effect may not be reducible to a specific type of probiotic bacteria
Probiotics seem to be effective in improving memory abilities including spatial and non-spatial memory both in rodents and humans Moreover specifically regarding the beneficial effect of probiotics on anxiety depression and stress preliminary evidence in humans is compelling However methodologically sound randomized-controlled trial RCT blind studies are still lacking
To sum up the present study is going to be the first RCT with human participants that investigates structural and functional changes of the hippocampus through probiotic bacteria using Magnet Resonance Imaging MRI In addition the study aims at advancing research in the field by investigating the effects of probiotics on a broad spectrum of cognitive functions particularly those associated with hippocampal activity eg spatial memory verbal memory Furthermore effects on several types of mental illness eg anxiety depression stress will be studied Potential translatory mechanisms that may promote the aforementioned effects will be examined ie changes in immunological parameters brain derived neurotrophic factor BDNF and oxytocin
Detailed Description:
A double-blind RCT intervention study will be conducted to investigate the effect of a probiotic dietary supplement vs a placebo taken by healthy human participants N 60 for 28 consecutive days Both substances are administered in doses of 44g powder per day
The probiotic dietary supplement used in the present study is a freely available product in powder form sold under the name of Vivomixx Per 44g the powder contains 450 billion bacteria composed of eight bacterial strains Lactobacilli L paracasei L plantarum L acidophilus and Ldelbrueckii subsp bulgaricus Bifidobacteria B longum B infantis B breve and Streptococcus thermophiles
This product was chosen because a similar supplement with an identical composition of bacteria as Vivomixx was found to be linked to hippocampal neurogenesis in mice The placebo powder has a similar taste and consistency as the verum Vivomixx powder but contains no probiotic bacteria
First participants will be screened online for eligibility T0 Before and after the 28-day intake period participants are asked to perform several cognitive tests and fill out questionnaires T1 T2 at our laboratory ca 2 - 25 hours Afterwards blood samples will be drawn ca 5 minutes and a magnet resonance tomography MRT session ca 1 - 15 hours will be conducted where participants will perform an object pattern separation task in the scanner T1 T2 Furthermore a follow-up after 2 months T3 including the same assessments as at T1 and T2 will be conducted
During the intake period participants will fill out a brief questionnaire on a weekly basis which includes an assessment of state depression and anxiety defecation control item to rule out adverse effects recent start of intake of medication recent onset of intake of antibiotics and recent inter-current illness eg influenza In addition participants will record their food intake protocol for one week 7 consecutive days during the intake period
The probiotic dietary supplement used in the present study is a freely available product in powder form sold under the name of Vivomixx Per 44g the powder contains 450 billion bacteria composed of eight bacterial strains Lactobacilli L paracasei L plantarum L acidophilus and Ldelbrueckii subsp bulgaricus Bifidobacteria B longum B infantis B breve and Streptococcus thermophiles
This product was chosen because a similar supplement with an identical composition of bacteria as Vivomixx was found to be linked to hippocampal neurogenesis in mice The placebo powder has a similar taste and consistency as the verum Vivomixx powder but contains no probiotic bacteria
First participants will be screened online for eligibility T0 Before and after the 28-day intake period participants are asked to perform several cognitive tests and fill out questionnaires T1 T2 at our laboratory ca 2 - 25 hours Afterwards blood samples will be drawn ca 5 minutes and a magnet resonance tomography MRT session ca 1 - 15 hours will be conducted where participants will perform an object pattern separation task in the scanner T1 T2 Furthermore a follow-up after 2 months T3 including the same assessments as at T1 and T2 will be conducted
During the intake period participants will fill out a brief questionnaire on a weekly basis which includes an assessment of state depression and anxiety defecation control item to rule out adverse effects recent start of intake of medication recent onset of intake of antibiotics and recent inter-current illness eg influenza In addition participants will record their food intake protocol for one week 7 consecutive days during the intake period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None