NCT02040922Unknown不适用
An Observational Study of the Role of Antibiotics, Inflammation and Changes in Microbiota in the Development of Post-infective Bowel Dysfunction Following Infection With Campylobacter Jejuni or Coli
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Yes/ no: Post-Infective bowel dysfunction (PI-BD)
研究概览
简要总结
The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.
详细描述
The secondary research objectives are:
- To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms.
- To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
- •Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
- •Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
排除标准
- •Pregnancy declared by the candidate
- •History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:
- •Inflammatory Bowel Disease
- •Coeliac Disease
- •Pancreatitis
- •Gallstone disease (biliary colic, cholecystitis)
- •Diverticulitis
- •Cancer of the gastrointestinal tract
- •Irritable Bowel Syndrome
- •Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
- •Intestinal stoma
- •Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
- •Use of antibiotics in the preceding four weeks other than for treatment of index infection.
- •Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection.
- •Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
- •Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding
- •Declared participation in any medical trials in the past 3 months
- •Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
结局指标
主要结局
Yes/ no: Post-Infective bowel dysfunction (PI-BD)
时间窗: 12 weeks after microbiological diagnosis of infection
This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"
次要结局
- Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)(12 weeks after microbiological diagnosis of infection)
研究者
研究点 (1)
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