EUCTR2017-004772-65-DK进行中（未招募）1 期
Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO
ParaTech A/S0 个研究点目标入组 120 人开始时间: 2017年12月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Patients who meet all of the following criteria can be enrolled into the trial:
- •1.Signed informed consent
- •2.Between 18 and 75 years of age
- •3.Established diagnosis of UC confirmed by endoscopic (sigmoidoscopy) and histological criteria, within 3 months prior to screening
- •4.Disease extension corresponding to E2 (left side colitis) or E3 (extensive colitis) according to the Montreal Classification, i.e. at least 15 cm from anal verge, confirmed by an index sigmoidoscopy
- •5.Mayo-score between 6 and 10 and including 6 and 10 corresponding to moderately active disease
- •6.Calprotectin = 250 µg/g and an endoscopic Mayo score = 2
- •7.Negative pregnancy test in females of childbearing potential and the use of birth control
- •8.No treatment or if treated with 5-Aminosalicyl acid (5-ASA): 5-ASA = 8 weeks with a stable dose for at least 4 weeks both oral and rectal use
- •9.Tapered down from last oral steroid = 4 weeks ago
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients who meet one of the following criteria, are not allowed to be enrolled into the trial:
- •1.Disease extension corresponding only to E1 (proctitis), i.e. less than 15 cm from the anal verge
- •2.Bowel surgery, except appendectomy and removal of polyps
- •3.Septic complications
- •4.Evidence of infectious diarrhea (e.g. pathogenic bacteria or Clostridium difficile toxin in stool)
- •5.Abscess, perforation, active fistula or perianal lesions
- •6.Abnormal hepatic function (ALAT or ALP > 2.5 x ULN at screening), liver cirrhosis, or portal hypertension
- •7.Abnormal renal function (Creatinine > ULN) at screening
- •8.Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance or the interpretation of the results
- •9.Any condition associated with significant immunosuppression
- •10.Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-a agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months prior to baseline
- •11.Treatment with systemic broad-spectrum antibiotics (e.g., metronidazole or ciprofloxacin), anti-parasitic medications, or probiotic (e.g. facal transplantation) medication within the last 4 weeks prior to baseline, except for probiotic lactobacillus or bifidobacteria within 2 weeks prior to baseline (and minimum 1 week before screening visit (sampling and biopsies))
- •12.Treatment with systemic glucocorticosteroid within the last 4 weeks or treatment with topical steroid within the last 2 weeks prior to baseline
- •13.Application of systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit for more than 3 consecutive days, except acetylsalicylic acid = 350 mg/d which is allowed
- •14.Immunization with live vaccines within 12 weeks prior to baseline or during the trial (the Corona vaccines are not per se live vaccine)
- •15.Travelling to rural districts in countries outside of Europe, USA, Australia or Canada within the last 12 weeks prior to baseline or during trial participation. If patients travel outside of Europe, USA, Australia or Canada they must be tested negative in the standard stool tests (parasites, bacteria and virus) when they return, as at the screening visit.
- •16.Well-founded doubt about the patient’s cooperation, (e.g., addiction to alcohol or drugs).
- •17.Existing or intended pregnancy or breast-feeding
- •18.Participation in another clinical trial within the last 60 days, simultaneous participation in another clinical trial
研究者
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