NCT03565939已完成2 期
Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
ParaTech A/S2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2018年5月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Remission (Full Mayo)
研究概览
简要总结
The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative, exploratory phase II proof of concept trial. The trial will be conducted with 2 treatment groups as a parallel group comparison and will serve to compare a 7500 TSO regimen vs. placebo for achieving clinically meaningful responses in Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Between 18 and 75 years of age
- •Established diagnosis of UC confirmed by endoscopic (sigmoidoscopy) and histological criteria, at least 3 months prior to inclusion
- •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
- •Mayo-score between 6 and 10 and including 6 and 10 corresponding to moderately active disease
- •Calprotectin ≥ 250 µg/g and an endoscopic Mayo score ≥ 2
- •Negative pregnancy test in females of childbearing potential and the use of an acceptable effective method of contraception
- •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
- •Tapered down from last oral steroid ≥ 4 weeks ago
排除标准
- •Disease extension corresponding only to E1 (proctitis), i.e. less than 15 cm from the anal verge
- •Bowel surgery, except appendectomy and removal of polyps
- •Septic complications
- •Evidence of infectious diarrhea (i.e. pathogenic bacteria or Clostridium difficile toxin in stool)
- •Abscess, perforation, active fistula or perianal lesions
- •Abnormal hepatic function (ALAT or ALP > 2.5 x ULN at screening), liver cirrhosis, or portal hypertension
- •Abnormal renal function (Creatinine > ULN) at screening
- •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
- •Any condition associated with significant immunosuppression
- •Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months prior to baseline
- •Treatment with systemic broad-spectrum antibiotics (e.g. metronidazole or ciprofloxacin), anti-parasitic medications, or probiotic (e.g. fecal transplantation) medication within the last 4 weeks prior to baseline, except for probiotic lactobacillus or bifidobacteria within 2 week prior to baseline (and minimum 1 week before screening visit (sampling and biopsies)).
- •Treatment with systemic glucocorticosteroid within the last 4 weeks or treatment with topical steroid within the last 2 weeks prior to baseline
- •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
- •Immunization with live vaccines within 12 weeks prior to baseline or during the trial
- •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.
- •Well-founded doubt about the patient's cooperation, (e.g., addiction to alcohol or drugs).
- •Existing or intended pregnancy or breast-feeding
- •Participation in another clinical trial within the last 60 days, simultaneous participation in another clinical trial
结局指标
主要结局
Remission (Full Mayo)
时间窗: 24 weeks
To achieve clinical remission defined as full Mayo score ≤ 2 at 24 weeks (long-term efficacy) (ITT, PP). The full Mayo score (range 0-12) is the sum of 4 clinical scores (stool frequency, rectal bleeding, mucosal appearance at endoscopy, physician rating of disease activity) each scored with a value 0 (normal), 1, 2, or 3 (worst).
次要结局
- Endoscopic remission(24 weeks)
- Response (Full Mayo)(24 weeks)
- Steroid free remission (Full Mayo)(24 weeks)
- Time to response(0-24 weeks)
- Symptomatic remission(12 and 24 weeks)
- Time to remission(0-24 weeks)
- Disease severity(12-24 weeks)
研究者
研究点 (2)
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