跳至主要内容
临床试验/NCT06182293
NCT06182293招募中不适用

Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Alpha diversity of the periodontal microbiota using Chao-1 index

研究概览

简要总结

Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background. Patients show a wide spectrum of clinical features including periodontitis, which is an inflammatory disease of the tooth-supporting tissues resulting from dysbiosis of the periodontal microbiota guided by inflammophilic bacteria.

The microbiota plays a fundamental role in the induction, training, and function of the host immune system. Numerous studies have highlighted the impact of an altered microbiota, i.e. dysbiosis, on the pathogenesis of immune-mediated diseases. Indeed, commensals are important to maintain immune homeostasis and changes in the microbial composition can be responsible for a loss of tolerance. SSc has been shown to be associated with gut dysbiosis and a depletion of commensals. However, although the oral cavity is one of the two largest microbial habitats, only one study (only focusing on Lactobacillus species) has investigated the oral microbiota in SSc. As periodontal dysbiosis is known to induce low-grade systemic inflammation and represents a risk factor for the development of various autoimmune diseases, the relationship between periodontal microbiota composition and SSc merits further exploration.

The aim of this pilot study is to characterize the taxonomic composition and metabolic pathways of the periodontal microbiota in SSc patients and age and sex-matched controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Common inclusion criteria
  • •Men or women over 18 (adults)
  • •Affiliation to a social health insurance plan
  • •Subject able to understand the aims and risks of the research and to give signed informed consent form prior to the inclusion in the study
  • •More than 12 teeth suitable for evaluation
  • •Inclusion criteria for systemic sclerosis patients
  • •Systemic sclerosis patient with a diagnosis based on the American College of Rheumatology/European League Against Rheumatism criteria (LeRoy et al., 1988 ; van den Hoogen et al., 2013)
  • •Diagnosis made during the 2 years preceding study inclusion (early form of the disease)
  • •Inclusion criteria for controls
  • •- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation

排除标准

  • •- Subject under court protection
  • •Subject under guardianship or curatorship
  • •Pregnancy or breastfeeding
  • •Impossibility to provide accurate information (emergency situation, comprehension difficulties…)
  • •Subject currently involved in another clinical trial or in an exclusion period following participation in another clinical trial
  • •Smoking (≥ 10 cigarettes per day)
  • •Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and/or anti-SSB auto-antibodies, systemic lupus erythematosus…)
  • •Progressive chronic illness other than systemic sclerosis
  • •Acute infection at inclusion
  • •Progressive cancer or cancer diagnosed within 2 years prior to the study
  • •Ongoing antibiotic and/or antifungal treatment or within 3 months prior to inclusion
  • •Probiotics and/or prebiotics intake within 3 months prior to inclusion
  • •Oral antiseptics within the week before inclusion (chlorhexidin mouthwashes…)
  • •Risk of infective endocarditis
  • •Corticosteroids ≥10 mg/day and/or proton pump inhibitors within 3 months prior to inclusion
  • •Previous hematopoietic stem cell transplantation
  • •Another cause of skin sclerosis (radiotherapy of the orofacial area…)
  • •Periodontal specialized treatments, root and/or periodontal surgical treatment and/or subgingival instrumentation within the year before inclusion

研究组 & 干预措施

Controls

Other

干预措施: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota (Other)

Systemic sclerosis

Other

干预措施: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota (Other)

结局指标

主要结局

Alpha diversity of the periodontal microbiota using Chao-1 index

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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