Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Changes in IBS-like symptomatology
研究概览
简要总结
The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
- •Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
- •Subjects aged over 18 years
- •Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) > 175.
排除标准
- •Presence of flare-up of UC
- •Coeliac disease, colectomy, or intestinal resection
- •Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
- •Any malignancy, pregnancy, or breastfeeding
- •Intake of medication potentially influencing gastrointestinal function
- •Disability to give informed consent
结局指标
主要结局
Changes in IBS-like symptomatology
时间窗: Measurements were assessed at baseline (T0) and eight weeks (T1)
Changes in IBS-like symptomatology were tested by IBS-Symptom Severity Score. The overall IBS-SSS score was calculated by totalling the punctuation of its five items. Each ranged from 0 to 100: (i) abdominal pain, (ii) number of days of abdominal pain during the last 10 days (number of days with abdominal pain x10), (ii) abdominal distension, (iv) satisfaction of defecatory behaviour, (v) interference of IBS symptoms in life. The possible range was then 0-500.
次要结局
- Changes in the abundance of bacterial markers(Measurements were assessed at baseline (T0) and eight weeks (T1))
研究者
Xavier Aldeguer
Head of Gastroenterology Department
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta