NCT01276626已完成1 期
Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression (HAD) scale.
研究概览
简要总结
The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria
- •Symptoms of mild to moderate anxiety and depression
排除标准
- •Concurrent systemic disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- •Concurrent organic Gastrointestinal (GI) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli.
- •Psychiatric diagnosis other than anxiety or depression.
- •Patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics
- •History of active cancer in the last 5 years, other than skin basal cells cancer
- •Pregnant or breastfeeding women
- •Treatment with antibiotics during the three months prior the study.
- •Known or suspected allergies to the study products (eg maltodextrin).
- •Patients who have heart pacemakers, metal implants, metal chips or clips in or around the eyeballs, artificial heart valves, metallic ear implants, bullet fragments or fixed brackets.
- •High fiber diet (>35 g/day for males, > 25 g/day for females), consumption of high inulin containing foods (>5 g/day).
- •Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the beginning of the study.
结局指标
主要结局
Hospital Anxiety and Depression (HAD) scale.
时间窗: 6 weeks post-treatment initiation
Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.
次要结局
- Improvement in IBS symptoms.(6 and 10 weeks post-treatment)
- Improvement in objective biomarkers.(6 weeks post-treatment)
研究者
研究点 (2)
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