Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters
NCT ID: NCT06638606
Last Updated: 2025-01-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ENROLLING_BY_INVITATION
Total Enrollment
1740 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-10-08
Study Completion Date
2026-12-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20 and - 80 ◦C) until further processing. On Day 1 and Day 2, all couples will participate in an oral, conjunctival and gut microbiota composition study. Optometry examinations will be completed for each participant Three and Six months later, oral, conjunctival and gut microbiota composition will be analyzed again with the same protocol. The participants will complete a validated Persian version 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 undergo a standard ophthalmology exam and specific assessments for dry eye, including non-anesthetic Schirmer's test and fluorescein tear break-up time on Day 1 and Day 90.
Consecutive couples will undergo a standard ophthalmology exam and specific assessments for dry eye, including non-anesthetic Schirmer's test and fluorescein tear break-up time on Day 1 and Day 90.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
NCT02086032
Menopausal and Postmenopausal Disorders
COMPLETED
NA
Gonadal Steroid Manipulation and Personality Characteristics: Association With Mood Fluctuations and in Vitro Fertilization (IVF) Outcomes
NCT01032421
Mood Disorders
COMPLETED
An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls
NCT05694481
Circadian Rhythm Disorders
Intestinal Flora
UNKNOWN
Impact of Reproductive Problems on Couples
NCT03365830
Infertility
UNKNOWN
Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
NCT06115590
Mood
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Salivary samples were collected from all participant. Couples were instructed not to consume any food or drink, except water, for at least 30 min prior to sample collection. Saliva cortisol was then measured by LC-MS/MS as described before.
The validated Persian version Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and Pittsburgh Sleep Quality Index (PSQI) will be employed to measure depression, anxiety, and sleep quality, respectively.
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 hours during the 32-hour recording. SPSS software will be used to analyze the data.
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
* Person-to-person bacterial transmission can alter depression and anxiety 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.
Salivary samples were collected from all participant. Couples were instructed not to consume any food or drink, except water, for at least 30 min prior to sample collection. Saliva cortisol was then measured by LC-MS/MS as described before.
The validated Persian version Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and Pittsburgh Sleep Quality Index (PSQI) will be employed to measure depression, anxiety, and sleep quality, respectively.
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 hours during the 32-hour recording. SPSS software will be used to analyze the data.
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
* Person-to-person bacterial transmission can alter depression and anxiety status in newly married couples through ocular microbiota
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Sleep Deprivation
Gut Microbiota
Optometry Examinations
Oral Microbiota
Depression
Anxiety
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Normal couples (have normal sleep pattern), B: Insomniac and C: hypersomniac couples
Group A: Couples with normal sleep pattern. Group B: One spouse suffers from insomnia. Group C: Once spouse suffers from hypersomnia.
Sleep improvement techniques
Intervention Type
BEHAVIORAL
Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep improvement techniques
Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sleep disorder (insomnia and hypersomnia)
* Depressive/anxiety states
* Depressive/anxiety states
Exclusion Criteria
* Medicines known to affect gut/oral/ocular microbiota composition
* Pregnant/pregnancy
* Divorce during the study
* Antibiotics use in the past month
* Ongoing, active ocular infection, including conjunctivitis.
* Not having any prior history with Dry eye disease
* Pregnant/pregnancy
* Divorce during the study
* Antibiotics use in the past month
* Ongoing, active ocular infection, including conjunctivitis.
* Not having any prior history with Dry eye disease
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Reza Rastmanesh
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Reza Rastmanesh
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reza Rastmanesh Principal investigator, unaffilaited, PhD
Role: PRINCIPAL_INVESTIGATOR
Abolfazl Sadeghinejad, MD
Role: STUDY_DIRECTOR
Javid Azizi, MD
Role: STUDY_DIRECTOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Private sleep clinic
Tehran, , Iran
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Iran
References
Explore related publications, articles, or registry entries linked to this study.
Zhang J, Lu X, Cheng Z, Zou D, Shi W, Wang T. Alterations of conjunctival microbiota associated with orthokeratology lens wearing in myopic children. BMC Microbiol. 2023 Dec 13;23(1):397. doi: 10.1186/s12866-023-03042-1.
Reference Type
BACKGROUND
Omar WEW, Singh G, McBain AJ, Cruickshank F, Radhakrishnan H. Gut Microbiota Profiles in Myopes and Nonmyopes. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):2. doi: 10.1167/iovs.65.5.2.
Reference Type
BACKGROUND
Wu Y, Fan H, Feng Y, Yang J, Cen X, Li W. Unveiling the gut microbiota and metabolite profiles in guinea pigs with form deprivation myopia through 16S rRNA gene sequencing and untargeted metabolomics. Heliyon. 2024 May 6;10(9):e30491. doi: 10.1016/j.heliyon.2024.e30491. eCollection 2024 May 15.
Reference Type
BACKGROUND
Zhang Y, Zhou X, Lu Y. Gut microbiota and derived metabolomic profiling in glaucoma with progressive neurodegeneration. Front Cell Infect Microbiol. 2022 Aug 12;12:968992. doi: 10.3389/fcimb.2022.968992. eCollection 2022.
Reference Type
BACKGROUND
Li H, Liu S, Zhang K, Zhu X, Dai J, Lu Y. Gut microbiome and plasma metabolome alterations in myopic mice. Front Microbiol. 2023 Dec 21;14:1251243. doi: 10.3389/fmicb.2023.1251243. eCollection 2023.
Reference Type
BACKGROUND
Sun Y, Xie Y, Li J, Hou X, Sha Y, Bai S, Yu H, Liu Y, Wang G. Study on the relationship between adolescent myopia and gut microbiota via 16S rRNA sequencing. Exp Eye Res. 2024 Oct;247:110067. doi: 10.1016/j.exer.2024.110067. Epub 2024 Sep 3.
Reference Type
BACKGROUND
Li H, Du Y, Cheng K, Chen Y, Wei L, Pei Y, Wang X, Wang L, Zhang Y, Hu X, Lu Y, Zhu X. Gut microbiota-derived indole-3-acetic acid suppresses high myopia progression by promoting type I collagen synthesis. Cell Discov. 2024 Aug 27;10(1):89. doi: 10.1038/s41421-024-00709-5.
Reference Type
BACKGROUND
Walters EM, Phillips AJ, Hamill K, Norton PJ, Drummond SP. Anxiety predicts dyadic sleep characteristics in couples experiencing insomnia but not in couples without sleep disorders. J Affect Disord. 2020 Aug 1;273:122-130. doi: 10.1016/j.jad.2020.04.031. Epub 2020 May 12.
Reference Type
BACKGROUND
Saini EK, Keiley MK, Fuller-Rowell TE, Duke AM, El-Sheikh M. Socioeconomic Status and Sleep among Couples. Behav Sleep Med. 2021 Mar-Apr;19(2):159-177. doi: 10.1080/15402002.2020.1721501. Epub 2020 Feb 2.
Reference Type
BACKGROUND
Gunn HE, Buysse DJ, Hasler BP, Begley A, Troxel WM. Sleep Concordance in Couples is Associated with Relationship Characteristics. Sleep. 2015 Jun 1;38(6):933-9. doi: 10.5665/sleep.4744.
Reference Type
BACKGROUND
Coutinho J, Pereira A, Oliveira-Silva P, Meier D, Lourenco V, Tschacher W. When our hearts beat together: Cardiac synchrony as an entry point to understand dyadic co-regulation in couples. Psychophysiology. 2021 Mar;58(3):e13739. doi: 10.1111/psyp.13739. Epub 2020 Dec 23.
Reference Type
BACKGROUND
Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.
Reference Type
BACKGROUND
Evangelista E, Lopez R, Barateau L, Chenini S, Bosco A, Jaussent I, Dauvilliers Y. Alternative diagnostic criteria for idiopathic hypersomnia: A 32-hour protocol. Ann Neurol. 2018 Feb;83(2):235-247. doi: 10.1002/ana.25141. Epub 2018 Feb 9.
Reference Type
BACKGROUND
Itani O, Kaneita Y, Munezawa T, Mishima K, Jike M, Nakagome S, Tokiya M, Ohida T. Nationwide epidemiological study of insomnia in Japan. Sleep Med. 2016 Sep;25:130-138. doi: 10.1016/j.sleep.2016.05.013. Epub 2016 Aug 30.
Reference Type
BACKGROUND
Chehri A, Goldaste N, Ahmadi S, Khazaie H, Jalali A. Psychometric properties of insomnia severity index in Iranian adolescents. Sleep Sci. 2021 Apr-Jun;14(2):101-106. doi: 10.5935/1984-0063.20200045.
Reference Type
BACKGROUND
Valles-Colomer M, Blanco-Miguez A, Manghi P, Asnicar F, Dubois L, Golzato D, Armanini F, Cumbo F, Huang KD, Manara S, Masetti G, Pinto F, Piperni E, Puncochar M, Ricci L, Zolfo M, Farrant O, Goncalves A, Selma-Royo M, Binetti AG, Becerra JE, Han B, Lusingu J, Amuasi J, Amoroso L, Visconti A, Steves CM, Falchi M, Filosi M, Tett A, Last A, Xu Q, Qin N, Qin H, May J, Eibach D, Corrias MV, Ponzoni M, Pasolli E, Spector TD, Domenici E, Collado MC, Segata N. The person-to-person transmission landscape of the gut and oral microbiomes. Nature. 2023 Feb;614(7946):125-135. doi: 10.1038/s41586-022-05620-1. Epub 2023 Jan 18.
Reference Type
BACKGROUND
Sheng D, Li P, Xiao Z, Li X, Liu J, Xiao B, Liu W, Zhou L. Identification of bidirectional causal links between gut microbiota and narcolepsy type 1 using Mendelian randomization. Sleep. 2024 Mar 11;47(3):zsae004. doi: 10.1093/sleep/zsae004.
Reference Type
BACKGROUND
Rakoff-Nahoum S, Foster KR, Comstock LE. The evolution of cooperation within the gut microbiota. Nature. 2016 May 12;533(7602):255-9. doi: 10.1038/nature17626. Epub 2016 Apr 25.
Reference Type
BACKGROUND
Busch A, Roy S, Helbing DL, Colic L, Opel N, Besteher B, Walter M, Bauer M, Refisch A. Gut microbiome in atypical depression. J Affect Disord. 2024 Mar 15;349:277-285. doi: 10.1016/j.jad.2024.01.060. Epub 2024 Jan 9.
Reference Type
BACKGROUND
Jezkova J, Sonka K, Kreisinger J, Prochazkova P, Tlaskalova-Hogenova H, Nevsimalova S, Buskova J, Merkova R, Dvorakova T, Prihodova I, Dostalova S, Roubalova R. Guardians of Rest? Investigating the gut microbiota in central hypersomnolence disorders. Sleep Med. 2024 Jan;113:95-102. doi: 10.1016/j.sleep.2023.11.024. Epub 2023 Nov 19.
Reference Type
BACKGROUND
Han M, Yuan S, Zhang J. The interplay between sleep and gut microbiota. Brain Res Bull. 2022 Mar;180:131-146. doi: 10.1016/j.brainresbull.2021.12.016. Epub 2022 Jan 13.
Reference Type
BACKGROUND
Wang Z, Wang Z, Lu T, Chen W, Yan W, Yuan K, Shi L, Liu X, Zhou X, Shi J, Vitiello MV, Han Y, Lu L. The microbiota-gut-brain axis in sleep disorders. Sleep Med Rev. 2022 Oct;65:101691. doi: 10.1016/j.smrv.2022.101691. Epub 2022 Aug 31.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
it24412
Identifier Type: OTHER
Identifier Source: secondary_id
IT. 24001670
Identifier Type: OTHER
Identifier Source: secondary_id
it24412
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress
NCT06127875
COMPLETED
Sleeping Through Menopause
NCT06306404
NOT_YET_RECRUITING
PHASE4
Sleep Quality and the Menstrual Cycle
NCT06906133
ACTIVE_NOT_RECRUITING
Chronobiological Basis of Menopausal Depression: Correcting Misaligned Circadian Rhythms With Sleep and Light Interventions
NCT06678880
RECRUITING
NA
Psychological Status and Related Factors of Thyroid Related Eye Disease
NCT03426696
COMPLETED
The Effects of Sex Hormones on Cognition and Mood in Older Adults
NCT00000175
TERMINATED
NA
Impact of Hot Flashes on Sleep and Mood Disturbance
NCT01116401
COMPLETED
PHASE4
Evaluation of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction
NCT06185309
NOT_YET_RECRUITING
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
NCT00113867
COMPLETED
Observation of Environment and Reproductive-Endocrine Effects
NCT06280807
RECRUITING
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
NCT00530582
COMPLETED
PHASE4
Effects of Sex Hormones on Circadian Rhythm in Men and Women
NCT00001285
COMPLETED
Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause
NCT06192641
COMPLETED
PHASE2
Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression
NCT02661789
COMPLETED
NA
Dietary Plant Hormone and Mental Health
NCT05276479
COMPLETED
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
NCT01988610
COMPLETED
PHASE1
Stress Reactivity and Hormonal Contraception
NCT06223126
ENROLLING_BY_INVITATION
Perimenopause-Related Mood and Behavioral Disorders
NCT00001231
COMPLETED
Circadian Rhythm Dysregulation in Offspring of Parents With Bipolar Disorder
NCT03656302
UNKNOWN
Stress Hormones and IUDs
NCT03499379
COMPLETED
Estrogen Variability and Irritability During the Menopause Transition
NCT05388656
COMPLETED
PHASE4
Menopause Age and Anxiety-Depression
NCT07295093
COMPLETED
Relation Between Emotional Stress and Infertility
NCT02822872
UNKNOWN
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
NCT06826755
RECRUITING
NA
Psychiatric Disorders With Prolonged Infertility
NCT03569215
COMPLETED