EUCTR2016-001240-19-BG进行中（未招募）1 期
Clearance of the probiotic strain Escherichia coli Nissle 1917 in the gastrointestinal tract of healthy volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Synlogic
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.No pre-existing medical conditions based on medical history and physical examination
- •2.Non-smoking
- •3.Male and female volunteers, aged 18-55 years
- •4.Normal weight according to the BMI (accepted range 18.5 to 30.0 kg/m2)
- •5.Regular bowel habits including consistency, frequency (4-14 stools per week)
- •6.Willingness to commit to no major dietary changes to daily carbohydrate and protein intake during the trial and until 2 weeks after last administration
- •7.Negative pregnancy test for all females of childbearing potential at entry visit
- •8.Signed written informed consent by subject
- •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 58
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of Mutaflor (or any other probiotic product) within 12 months prior to study initiation
- •2.Use of any investigational drug or antibiotics within 60 days prior to study initiation
- •3.Baseline EcN positivity by PCR assay of stool sample
- •4.Active infection (viral or bacterial)
- •5.Active GI disease (current or within past 6 months) including nausea, vomiting, diarrhea, constipation, abdominal pain, malabsorption, GI bleeding, inflammatory bowel disease, or any other condition that could affect Mutaflor passage or activity in the GI tract or cause fluctuations in GI signs/symptoms
- •6.Any previously diagnosed inflammatory bowel disease or irritable bowel syndrome
- •7.Major surgery of the gastrointestinal tract except for appendectomy
- •8.History of immune-compromised condition (e.g., AIDS, lymphoma, subjects undergoing corticosteroid treatment)
- •9.Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- •10.Hypersensitivity to the active substance in Mutaflor or to any of the excipients
- •11.Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity)
- •12.Laboratory values outside the normal range that are determined to be clinically significant by the investigator
- •13.Other severe chronic medical conditions or other active diseases that should be excluded, based on clinical assessment of the investigator
- •14.Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg at entry visit
- •15.Heart rate outside the range of 50 to 90 beats/min at entry visit
- •16.Body temperature (axillary) outside the interval of 35.5 to 37.1°C at entry visit
- •17.Any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
- •18.Special diet due to any reason, e.g. vegetarians
- •19.Subjects expected not to be able to fulfil study specific restrictions given in chapter 9.4 Restrictions of the study protocol
- •20.Pregnant and/or nursing women. Positive pregnancy test on day 0
- •21.Fertile women without reliable contraception method.
- •List of medically accepted contraceptive methods (used at least 4 weeks prior entry visit and not to be changed for the duration of the study):
- •a.combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
- •b.hormonal methods: combined estrogen/progestin injectable and oral contraceptives, progestin injectable and oral contraceptives, Norplant implants, skin patches, NuvaRing®
- •c.intrauterine devices (IUD): inert or copper-releasing or progestin-releasing IUD
- •d.voluntary sterilization (female tubal occlusion)
- •22.History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
- •23.Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
- •24.Positive drug screening and/or positive alcohol test at entry screening or on day 0
- •25.Subjects who are known or suspected:
- •a.not to comply with the study directives
- •b.not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed con
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