Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616937
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-10-28
Brief Title:
Prebiotics and Mental Health Behavioural
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health Behavioural
Status:
COMPLETED
Status Verified Date:
2020-11
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:
None
Brief Summary:
A behavioural study of the microbiota-gut-brain axis in brain development and mental health
Detailed Description:
Research suggests that modifying microbial ecology therapeutically via the intake of so-called psychobiotics could help reduce stress responses and symptoms of anxiety and depression Burnet Cowen 2013 Dinan Stanton Cryan 2013 Tang Reddy Saier 2014 The term psychobiotics refers to both beneficial gut bacteria probiotics as well as prebiotics which enhance the growth of beneficial gut bacteria Sarkar et al 2016 In a recent study Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers Schmidt et al 2015 They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides Bimuno intake over 4 weeks compared with placebo Moreover participants exhibited decreased attentional vigilance to negative information in a dot-probe task Given that anxious people show increased biases towards negative information Bar-Haim Lamy Pergamin Bakermans-Kranenburg van 2007 this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms
These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning psychological well-being and gut microbiota a sample of 60 undergraduate students aged 18-25 years
At time 1 pre-assessment participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being such as anxiety levels and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome Group 1 will then receive a daily dosage of a galactooligosaccharide GOS prebiotic over 4 weeks whereas group 2 will receive a placebo over the same period At time 2 post-assessment both groups will again undergo cognitive and psychological testing and stool sampling
Hypothesis It is predicted that the treatment group GOS will show improvements in behavioural indices of emotion regulation eg dot probe task and in self reported psychological measures related to emotion regulation eg anxiety in comparison to the placebo group Changesdifferences in gut microbiome samples will be explored
These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning psychological well-being and gut microbiota a sample of 60 undergraduate students aged 18-25 years
At time 1 pre-assessment participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being such as anxiety levels and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome Group 1 will then receive a daily dosage of a galactooligosaccharide GOS prebiotic over 4 weeks whereas group 2 will receive a placebo over the same period At time 2 post-assessment both groups will again undergo cognitive and psychological testing and stool sampling
Hypothesis It is predicted that the treatment group GOS will show improvements in behavioural indices of emotion regulation eg dot probe task and in self reported psychological measures related to emotion regulation eg anxiety in comparison to the placebo group Changesdifferences in gut microbiome samples will be explored
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