2024-517764-38-00招募中2 期
A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery. A clinical safety and proof-of-concept study
Region Sjaelland, Reponex Pharmaceuticals A/S1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年9月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in the pouchitis disease activity index (PDAI
研究概览
简要总结
We aim to investigate whether GM-CSF in combination with metronidazole and fosfomycin, applied topically in the pouch, can be used in patients with pouchitis. As pouchitis seems to mimic Crohn’s disease, and responds to therapy used in Crohn’s disease, we suspect that this combination therapy can target the bacterial dysbiosis and inadequate immune response in pouchitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Of any gender • Over 18 years of age • Have a previous diagnosis of ulcerative colitis • Have had IPAA surgery, and • Have been diagnosed with pouchitis • Be able to understand and complete study procedures as determined by the investigator • Be able to speak either Danish or English • Be able to comply with study procedures for the length of the study • Use a highly effective contraception method for the duration of the trial (until day 30 in Phase I and until day 37 in Phase II), such as implants, injectables, oral contraceptives, IUD (intrauterine device), sexual abstinence or vasectomized partner.
排除标准
- •Patients with a previous allergic reaction to GM-CSF, metronidazole or fosfomycin • Patients who are currently under antibiotic treatment or have received antibiotic treatment within the past 30 days • Patients currently pregnant or breastfeeding • Patients with ASA IV classification (American Society of Anesthesiologists physical status classification) • Patients with severe pulmonary disease • Patients with autoimmune thrombocytopenia • Patients with severe renal impairment (eGFR < 40 ml/min) • Patients with alcohol use disorder or history of drug abuse • Patients currently in treatment for any malignant or hematological disease • Patients with a previous history of cancer will be excluded from the study (except for patients with well-treated and stabile cancer after a control period of more than two years). • Patients with anticipated compliance problems as determined by the investigator
结局指标
主要结局
Change in the pouchitis disease activity index (PDAI
Change in the pouchitis disease activity index (PDAI
次要结局
- Change in the clinical, endoscopic or histological PDAI
- Change in median WBC, CRP, creatinine and liver enzymes from before application of the study drug to 7 days after application of the study drug
- Change in microbial diversity in the pouch using 16S rRNA sequencing from before application of the study drug to 7 days after application of the study drug
- Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch
- Assess the modulation of dendritic cells and inflammatory mechanisms using Nanostring nCounter analysis through mRNA expression and flow cytometry
研究者
Ismail Gögenur
Scientific
Region Sjaelland
研究点 (1)
Loading locations...
相似试验
招募中
1 期
GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA SurgeryPouchitisNCT04979832Zealand University Hospital18
已完成
不适用
G-CSF in treatment of premature neonates with neutropenia and clinical sepsisneonatal sepsis.Other infectious diseasesIRCT201303252639N11Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .40
暂停
不适用
EXtended use of FOsfomycin for the treatment of CYstitis in primary careNL-OMON25501MC Utrecht777
进行中（未招募）
1 期
EXtended use of FOsfomycin for the treatment of CYstitis in primary careEUCTR2020-005337-33-NLniversity Medical Center Utrecht741
已完成
4 期
EXtended use of FOsfomycin for the treatment of CYstitis in primary careurinary tract infectionCystitisNL-OMON50944niversitair Medisch Centrum Utrecht777