DRKS00034330尚未招募Unknown
Modulation of the gut microbiome in ulcerative colitis patients
Institut Allergosan Pharmazeutische Produkte Forschungs- und Vertriebs GmbH0 个研究点目标入组 24 人开始时间: 2024年5月24日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent for the trial
- •Confirmed diagnosis of UC = 6 months, confirmed by endoscopy
- •Remission or mild disease defined by partial adapted Mayo score (MMS) = 3 verified during screening period
- •Subjects with documented adequate response to at least one of the following treatments:
- •stable therapy for at least 3 months with 5-ASA, immunosuppressants, biologic therapies, JAK inhibitors, sphingosine 1-phosphate (S1P) receptor modulators and/or any new drug approved during the study period
- •Have adequate organ function in the opinion of the investigator
- •A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at screening visit.
排除标准
- •Subjects with Crohn`s disease, presence or history of fistula, indeterminate colitis, infectious/ischemic colitis, microscopic colitis or celiac disease.
- •Current evidence of toxic megacolon, fulminant colitis, bowel perforation.
- •Recent (within the last 3 months) or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma or pouch.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- •Subject with the following oral/ rectal/ s.c. / i.v. treatments within the last four weeks: prednisone or prednisone equivalents, beclomethasone dipropionate or budesonide MMX, any antibiotic therapy
- •Active bacterial infection requiring oral or systemic antibiotic therapy
- •Subjects who have completed a course of antibiotics within four weeks prior to first dosing
- •Intake of probiotics within four weeks prior to first dosing
- •Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial
- •Any medical condition of health disorders that prevents from participating the clinical trial in the opinion of the investigators
- •Serologic evidence of HIV infection, or active infection with hepatitis B or C
- •Any disease or syndrome causing immunodeficiency in the opinion of the treating investigator
- •Any malignancies within the last 2 years
- •Any disease requiring immunosuppressive or immunomodulatory treatment which makes the patient inapplicably for a participation in the trial in the opinion of the investigator
- •Patients with a BMI > 35 kg/m2 or any other condition preventing the use of the sedative propofol in the opinion of the investigator
- •Female subjects that are pregnant or breastfeeding at screening visit.
研究者
相似试验
招募中
不适用
Exploring the modulatory effects of gut microbiota on cholangiocarcinoma progression in a patient-derived organoid modelC22.1Intrahepatic bile duct carcinomaCholangiocarcinomaDRKS00033188nimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie20
已完成
不适用
Modulation of the intestinal microbiome, and its effects on endurance exercise capacity in moderately trained individualsNL-OMON49125niversiteit Maastricht34
招募中
Unknown
Study of the gut microbiota modulatory potential of two popular drinks in northern NigeriaDigestive SystemNutritional, Metabolic, EndocrineOral HealthPACTR202401853406618AUDU HARUNA JIMOH36
终止
2 期
Fecal Microbiota Transplantation as a Treatment for Ulcerative ColitisUlcerative ColitisNCT04434872Tel-Aviv Sourasky Medical Center80
招募中
不适用
Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptominactive IBD patients with IBS-like symptomJPRN-UMIN000041577Hyogo College of Medicine200