ACTRN12624000912583尚未招募Unknown
Microbial fermentative capacity of individuals with ulcerative colitis with an ileoanal pouch compared to a healthy or ulcerative colitis with intact colons: an in vitro study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Three cohorts of subjects will be recruited:
- •(1) Patients with UC-pouches
- •Patients with both current active pouchitis (n=10) and without pouchitis (n=10) will be recruited via social media, advertisements, word of mouth and the Alfred inflammatory bowel disease (IBD) clinic. Active pouchitis will be defined as PDAI >7 and without pouchitis will be a pouch disease activity index (PDAI) <7 as determined by histologic, clinical and endoscopic assessment. If patients are recruited from the Alfred, pouchoscopies will be completed via standard of care for patients who are already coming into attend the pouch clinic.
- •(2) n=20 patients with UC with mild to moderately disease activity (n=10) and patients in clinical remission (n=10) will be recruited via the same channels as the first cohort. Diagnosis of activity or remission was determined based on faecal calprotectin and the Partial Mayo questionnaire. If available, these results can also be confirmed with intestinal ultrasound to confirm findings and colonoscopy and histology reports.
- •(3) A total of 10 healthy controls with an intact colon and no history of gastrointestinal diseases (i.e. coeliac disease, inflammatory bowel disease) and no active investigations for gastrointestinal issues will be recruited from study flyers or word of mouth.
- •Apart from the inclusion criteria above, the following applies to all groups:
- •- Living in Metropolitan Melbourne
- •- 18-75 years old
- •- Ability to speak and read English
- •- Eligible for Medicare
排除标准
- •- Presence of Crohn’s disease, coeliac disease and indeterminate colitis
- •- Prebiotic, probiotic supplements in the last 2 weeks
- •- Antibiotic use (including sulfasalazine) in last 4 weeks except if they have pouchitis that is antibiotic-dependent.
- •- Unable to provide informed consent
研究者
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