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临床试验/NCT06638606
NCT06638606已完成不适用

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

Reza Rastmanesh1 个研究点 分布在 1 个国家目标入组 1,740 人开始时间: 2024年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,740
试验地点
1
主要终点
Sleep Pattern

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Sleep disorder (insomnia and hypersomnia)
  • •Depressive/anxiety states

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Sleep improvement techniques (Behavioral)

结局指标

主要结局

Sleep Pattern

时间窗: 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.

Optometry examinations

时间窗: 3 months

Depression

时间窗: 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

Anxiety

时间窗: 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.

次要结局

  • Dry eye symptom(at 3, 6 and 12 months will be measured using Ocular Surface Disease Index (OSDI) questionnaire)

研究者

发起方
Reza Rastmanesh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reza Rastmanesh

Principal Investigator

Shahid Beheshti University of Medical Sciences

研究点 (1)

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