Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638606
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Gut and Ocular Microbiota Profiles in Newly Married Couples Potential Effects on Vision and Sleep
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gut and Ocular Microbiota Profiles in Newly Married Couples Potential Effects on Vision and Sleep
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fecal and conjunctival samples will be collected from participants and will be stored at - 80 C until further processing On Day 1 and Day 2 all couples will participate in a gut microbiota composition study Optometry examinations will be completed for each participant Three months later gut microbiota composition will be analyzed again with the same protocol The participants will complete a validated Persian versions of Pittsburgh Sleep Quality Inventory PSQI Epworth Sleepiness Scale ESS Insomnia Severity Index ISI global sleep assessment questionnaire GSAQ and Ocular Surface Disease Index
Consecutive couples will underwent a standard ophthalmology exam and specific assessments for dry eye including non-anesthetic Schirmers test and fluorescein tear break-up time on Day 1 and Day 90
Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep Hypersomnia is defined by a bed-rest total sleep time 19 hour during the 32-hour recording SPSS software will be used to analyze the data
Consecutive couples will underwent a standard ophthalmology exam and specific assessments for dry eye including non-anesthetic Schirmers test and fluorescein tear break-up time on Day 1 and Day 90
Insomnia in this study is defined as coexistence of both daytime dysfunction and difficulty resuming sleep Hypersomnia is defined by a bed-rest total sleep time 19 hour during the 32-hour recording SPSS software will be used to analyze the data
Detailed Description:
The metabolic activity diversity and composition of the gut microbiota vary significantly between healthy individuals and insomniacs and also between hypersomniacs and healthy people While Clostridiales and Bacteroides are regarded to be the two most important biomarkers for differentiating between healthy people and insomniacs a recent study demonstrated that an enhanced relative abundance of five genera including Lachnospiraceae UCG010 Hungatella Collinsella Gordonibacter and Blautia may be correlated with a diminished risk of some types of hypersomnia narcolepsy type one Contrarily an enhanced relative abundance of class Betaproteobacteria genus Ruminiclostridium and genus Alloprevotella may potentially increase the risk of narcolepsy type one
Furthermore recent studies demonstrated that there were no significant differences in alpha and beta diversity between the three groups nonmyopes NM progressive myopes progressive myopes and stable myopes SM Nothwithstanding the distributions of Dorea Roseburia Faecalibacterium Coprococcus Bacteroides Bifidobacterium Megamonas and Blautia were significantly higher in the myopes SM and PM combined when compared with emmetropes The myopes showed significantly higher abundance of bacteria that are linked to the regulation of dopaminergic signalling such as Bacteroides Ruminococcus Clostridium Bifidobacterium Participants with stable myopia were found to have a significantly higher proportion of Prevotella copri than those with progressive myopia Bifidobacterium adolescentis a gamma-aminobutyric acid GABA-producing bacterium was significantly higher in all myopes than in NM and in the comparison between SM and PM it is significantly higher in SM B uniformis and B fragilis both GABA-producing Bacteroides were present in relatively high abundance in all myopes and in SM compared with PM respectively
Some researches have detected substantial bacterial strain sharing across people with distinct intra-population mother-to-infant and intra-household transmission patterns There was considerable strain sharing among cohabiting people with 32 and 12 median strain-sharing rates for the time since cohabitation and gut and oral microbiomes affected strain sharing more than genetics or age did
Based on these premises below hypotheses are proposed
Person-to-person bacterial transmission can change the sleep pattern in newly married couples through gut microbiota
Person-to-person bacterial transmission can alter vision status in newly married couples through ocular microbiota
Furthermore recent studies demonstrated that there were no significant differences in alpha and beta diversity between the three groups nonmyopes NM progressive myopes progressive myopes and stable myopes SM Nothwithstanding the distributions of Dorea Roseburia Faecalibacterium Coprococcus Bacteroides Bifidobacterium Megamonas and Blautia were significantly higher in the myopes SM and PM combined when compared with emmetropes The myopes showed significantly higher abundance of bacteria that are linked to the regulation of dopaminergic signalling such as Bacteroides Ruminococcus Clostridium Bifidobacterium Participants with stable myopia were found to have a significantly higher proportion of Prevotella copri than those with progressive myopia Bifidobacterium adolescentis a gamma-aminobutyric acid GABA-producing bacterium was significantly higher in all myopes than in NM and in the comparison between SM and PM it is significantly higher in SM B uniformis and B fragilis both GABA-producing Bacteroides were present in relatively high abundance in all myopes and in SM compared with PM respectively
Some researches have detected substantial bacterial strain sharing across people with distinct intra-population mother-to-infant and intra-household transmission patterns There was considerable strain sharing among cohabiting people with 32 and 12 median strain-sharing rates for the time since cohabitation and gut and oral microbiomes affected strain sharing more than genetics or age did
Based on these premises below hypotheses are proposed
Person-to-person bacterial transmission can change the sleep pattern in newly married couples through gut microbiota
Person-to-person bacterial transmission can alter vision status in newly married couples through ocular microbiota
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None