跳至主要内容
临床试验/NCT07512908
NCT07512908尚未招募不适用

Study of Factors Influencing the Dynamicsof Colonisation and Decolonisation of the Digestive Tract by Clostridioides Difficile in Infants

Fondation Hôpital Saint-Joseph0 个研究点目标入组 200 人开始时间: 2026年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants

研究概览

简要总结

Clostridioides difficile (formerly C. difficile) is a bacterium found in the form of spores (a resistant form) to which patients may be exposed in a hospital environment. Once ingested, the spore can germinate in the digestive tract in its vegetative form (active form of the bacterium) and then takes on the appearance of a Gram-positive bacillus that colonizes the digestive microbiota. This preliminary stage of digestive colonization by the bacterium is facilitated by certain factors, in particular exposure to antibiotics, which disrupt the composition of the digestive microbiota (dysbiosis) and thus facilitate the establishment of C. difficile following the removal of the barrier effect of the digestive microbiota. Certain strains (known as "toxinogenic") are then able to produce the main virulence factors (toxins A (TcdA) and B (TcdB)), thereby causing the main clinical signs of digestive infection, particularly in patients with risk factors for C. difficile infection (elderly people, progressive cancer, immunodepression, etc.).The treatment of CDI is mainly based on the oral administration of anti-Clostridioides difficile antibiotics such as Fidaxomicin (FDX) or Vancomycin (VAN) for a period of 10 days, according to the European recommendations of the ESCMID and the American recommendations of the IDSA. Despite effective treatment, CDI is characterized by a high recurrence rate of up to 25% of cases, with multiple recurrences that can be particularly debilitating for patients. The effect of disruption of the gut microbiota (dysbiosis) following exposure to antibiotics can be explained by several non-exclusive hypotheses, such as the disappearance of protective bacterial species in the gut microbiota or, conversely, the appearance of bacterial species that favor the colonization of C. difficile.

Hospitalization, and more generally healthcare, has often been identified as a risk factor for CDI.Indeed, C. difficile is found ubiquitously in the environment and contaminates food products. It is still difficult to assess the frequency of contamination through the ingestion of contaminated food and the potential colonization of the host.

Only the composition of the gut microbiota appears to be an interesting avenue to explore, especially since it changes significantly during the first year of life as important events occur, including dietary diversification with the introduction of the first solid foods.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • For mothers
  • Women aged 18 or over who are pregnant
  • Patients who have been informed and have consented to participate in the research
  • Patient affiliated with a health insurance plan (beneficiary or dependent), For minor patients (children)
  • unborn child
  • at least one parent of the child included is French-speaking
  • written consent from both parents for participation in the study criteria for non-inclusion parents under guardianship or trusteeship parents deprived of their liberty parents under judicial protection children born under X/or in foster care

排除标准

  • 未提供

研究组 & 干预措施

cohort follow-up

Other

The only intervention will be in women with a vaginal swab. For children, stool samples will be collected at specific points.

干预措施: cohort follow up (Other)

结局指标

主要结局

characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants

时间窗: 18 months

characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants from birth to 18 months of age.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验