跳至主要内容
临床试验/NCT03122795
NCT03122795已完成不适用

Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Region Skane2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年5月15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
Region Skane
入组人数
22
试验地点
2
主要终点
SNOT-22

研究概览

简要总结

Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and substantial societal costs. Though sometimes co-appearing with other conditions, such as asthma, allergy, and nasal polyps, many cases present without co-morbidities. Micro-biological diagnostic procedures are frequently undertaken, but the results are often inconclusive. Nevertheless, antibiotics are usually prescribed, but invariably with limited and temporary success. Accordingly, there is a need for new treatments for CRS.

Recent studies indicate that the sinuses are colonized by a commensal microbiome of bacteria and that damage to this natural microbiome, by pathogens or antibiotics, may cause an imbalance that may promote CRS. Therefore, treatments that restore the commensal microbiome may offer an alternative to current protocols. Arguably, as suggested by studies on patients with intestinal infections (next paragraph), one such possibility may be to transfer a "normal microbiome" to patients with CRS.

A disrupted microbiome is linked to intestinal clostridium difficile infections. Probiotic restitution therapy may be effective even in cases recalcitrant to antibiotic treatment. However, a key to effective probiotic restitution is selecting the bacteria that facilitate regrowth of normal microbiome. As an answer to this, researchers have chosen to simply transplant the entire microbiome from a healthy donor. In the case of clostridium difficile infection in the form of faecal transplants.

In this study, we will examine the possibility to treat patients with chronic rhinosinusitis without polyps (CRSsNP) with complete sinonasal microbiomes obtained from healthy donors. Our analysis will focus on symptoms and signs of disease as well as on nasal inflammatory and microbiological indices.

详细描述

Over the last few years the theory of a damaged microbiome as a cause or promoting factor behind chronic rhinosinusitis has gained increasing interest from the scientific community.

A number of studies aimed at investigating the microbiota of the nose and paranasal sinuses in health and disease has been published with very varying outcomes. Furthermore, other studies have been aimed at probiotic treatment of sinonasal disease either locally or through immunologic manipulation via the gastrointestinal microbiota.

A problem common to all these studies is that studies examining the normal nasal microbiota have identified a great amount of different bacterial species. It is as of today not known which individual species or combinations of species that promotes health.

The probiotic assemblages examined in previous studies have consisted of one or a combination of a few bacterial species.

Probiotic restitution therapy has been proven very effective for intestinal clostridium difficile infections. The restitution therapy has then consisted of transplantation of a complete microbiome from a healthy donor in the form of a faecal transplant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Microbiome transplant

Experimental

The only arm of the study. Patients suffering from CRSsNP gets microbiome transplants from donors without any sinonasal health problems.

干预措施: Microbiome transplant (Procedure)

结局指标

主要结局

SNOT-22

时间窗: Day 1 to day 106

Change of burden of disease as measured by the SNOT-22 (22 item sinonasal outcome test) questionnaire in patients

次要结局

  • Inflammatory burden(Day 1 to day 106)
  • Subjective symptom score(Day 1 to 106.)
  • Microflora(Day 1 to day 106)
  • Lund Kennedy endoscopy score(Day 1 to day 106)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Sinonasal Microbiome Transplant as a Therapy for... | 临床试验