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临床试验/NCT05405634
NCT05405634Unknown不适用

Microbiota in Chronic Anal Fissure and Its Association With Prognosis - Prospective Cohort Study

Lasse Krogsbøll0 个研究点目标入组 80 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
PICRUSt2

研究概览

简要总结

In this study, we will try to answer the following questions:

  1. What are the salient features of the microbiota in chronic anal fissure?
  2. Are these features associated with prognosis and response to therapy?
  3. Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?

详细描述

To allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. Previous studies have relied on culture, whereas we will employ molecular methods.

We will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. To see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. We will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. To examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap.

We will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

PICRUSt2

时间窗: 3 months

16S/18S RNA

时间窗: 3 months

Change from baseline in pain severity both during and after defecation

时间窗: 3 months

Numerical rating scale 1-10.

Healing of anal fissure after 3 months

时间窗: 3 months

Defined by complete patient-reported resolution of pain combined with healed fissure on clinical examination

次要结局

未报告次要终点

研究者

发起方
Lasse Krogsbøll
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lasse Krogsbøll

Sponsor-investigator

Bispebjerg Hospital

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