Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters

June 10, 2026 updated by: Reza Rastmanesh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

Study Type

Observational

Enrollment (Actual)

1740

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
      • Tehran, Iran, 1961835555
        • Private sleep clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All volunteer participants who had been officially married during the past six months and are in a cohabiting relationship will be invited to participate in this study together with their official spouses.

Description

Inclusion Criteria:

  • Sleep disorder (insomnia and hypersomnia)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Sleep improvement techniques
Insomniac and hypersomniac individuals are given behavioral counselling to improve sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Pattern
Time Frame: 3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory
Sleep quality and quantity will be evaluated using Pittsburgh Sleep Quality Inventory.
3 months later, sleep quality and quantity will be measured with Pittsburgh Sleep Quality Inventory
Optometry examinations
Time Frame: 3 months
3 months
Depression
Time Frame: 6 months later, will be measured using Beck Anxiety Inventory-II.
The BDI-II is a commonly utilized 21-item self-report inventory designed for assessing depressive symptomatology, referring to the last two weeks. Higher scores demonstrate more severe depressive symptomatology. Depression in this study was defined as a BDI-II score ≥14
6 months later, will be measured using Beck Anxiety Inventory-II.
Anxiety
Time Frame: 6 months later, will be measured using Beck Anxiety Inventory
BAI questionnaire has 21 items with scores ranging from 0-3 for each item, in which 0 indicates "not at all," 1 indicates "mildly, but it did not bother me much," 2 indicates "moderately, it was not pleasant at times," and 3 indicates "severely, it bothered me a lot" for all the items.
6 months later, will be measured using Beck Anxiety Inventory

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry eye symptom
Time Frame: at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire
Dry eye disease (DED) will be evaluated using Ocular Surface Disease Index questionnaire. DED is classified as mild (13-22 points), moderate (23-32 points), or severe (33-100 points).
at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reza Rastmanesh

Investigators

  • Principal Investigator: Reza Rastmanesh Principal investigator, unaffilaited, PhD
  • Study Director: Abolfazl Sadeghinejad, MD
  • Study Director: Javid Azizi, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

November 14, 2024

Study Completion (Actual)

November 14, 2024

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSF: 98R026323-2024 (Other Identifier: National Science Institute, Iran)
  • IT. 24001670 (Other Identifier: National Science Foundation, Iran)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Oral, fecal and conjunctival samples will be collected from participants and will be stored according to the standard protocols 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 version of Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), and global sleep assessment questionnaire (GSAQ). 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.

For more detail, contact me: r.rastmanesh@gmail.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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