The effect of probiotics on the incidence of spontaneous bacterial peritonitis in patients with cirrhosis and ascites. - VSL#3

ottingham University Hospital NHS Trust0 个研究点目标入组 10 人开始时间: 2011年2月17日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Participant is willing and able to give informed consent for participation in the study.
•Male or Female, aged 18 years or above.
•Diagnosed with required disease/severity/symptoms
•Stable dose of current regular medication (e.g. diuretics, beta-blockers, vitamin supplementation) for at least 4 weeks prior to study entry.
•Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
•Participants have clinically acceptable laboratory and ECG within 14 days of enrolment.
•Able (in the Investigators opinion) and willing to comply with all study requirements.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
•Presence of hepatocellular carcinoma
•Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
•Participant who is terminally ill or is inappropriate for placebo medication
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
•Use of antibiotics or probiotics in the last 2 weeks
•Participants who have participated in another research study involving an investigational product in the past 12 weeks

发起方

ottingham University Hospital NHS Trust