NL-OMON55227已完成2 期
Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn*s Disease (CD): a pilot study - PAZAZ
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Provision of signed and dated informed consent form (and assent form, as
- •applicable)
- •2. Stated willingness to comply with all study procedures and availability for
- •the duration of the study
- •3. Male or female, aged 3 to 17 years
- •4. Diagnosed with CD according to standard clinical and histological criteria,
- •within 36 months of week 0
- •5. Exhibiting mild to moderate symptoms of active disease, as determined by a
- •PCDAI score >10 (or >7.5 excluding the height item) and <=37.5
- •6. Evidence of active inflammation based on either: fecal calprotectin level
- •>=250 microgram/g (local laboratory or pre-arranged sponsor testing) within 30
- •days prior to week 0 visit; or according to accepted endoscopic and histologic
- •evidence obtained during an endoscopy procedure completed within 30 days prior
- •to Week 0 Visit.
排除标准
- •1.Current or previous use of anti-TNF or other biologic therapy
- •2.Presence of stricturing, penetrating (intestinal or perianal) and/or
- •fistulizing CD.
- •3.Pregnancy or lactation
- •4.Have undergone intestinal resection
- •5.Laboratory diagnosis of Clostridium Difficile Infection (CDI), if performed
- •for clinical indication
- •6.Treatment with another investigational drug or other intervention within 30
- •days before week 0
- •7.Risk factors for arrhythmia including history of prolonged QTc, hypokalemia
- •or hypomagnesemia, resting bradycardia, or concurrent treatment with other
- •drugs with potential for QT prolongation.
- •8.History of Cockayne syndrome
- •9.Prior diagnosis of any hematologic condition/blood dyscrasia which may result
- •in leukopenia (even if leukocyte count is normal at screening)
- •10.Known allergy or intolerance to azithromycin or metronidazole
- •11.Subjects who received IV anti-infective within 35 days prior to week 0 visit
- •or oral anti-infectives within 14 days prior to the week 0 visit.
- •12.Subject on oral aminosalicylates who has not been on stable doses for
- •greater than, or discontinued within, at least 14 days prior to week 0.
- •13.Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses
- •(no change within 14 days prior to week 0) of Azathioprine, 6-mercaptopurine or
- •MTX are not a reason for exclusion.
- •14.Subject who received fecal microbial transplantation within 35 days prior to
- •week 0 visit.
- •15.Screening laboratory and other analyses show any of the following abnormal
- •o AST, ALT > 2 X upper limit of the reference range (as determined locally at
- •o Urea, Creatinine > 1.5X upper limit of the reference range (as determined
- •locally at each site)
- •o White blood cell (WBC) count < 3.0 X 109/L
- •o Total bilirubin >= 20 micromol/liter (1.17mg/dl); except for subjects with
- •isolated elevation of indirect bilirubin relating to Gilbert syndrome
- •o Hemoglobin < 80 gram/liter
- •o Platelets < 100,000/µL
研究者
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