The Use of VSL#3 in Irritable Bowel Syndrome in Children
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The Gastrointestinal Symptom Rating Scale
研究概览
简要总结
The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.
详细描述
Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children should fulfill Rome ll criteria for IBS.
- •Organic disease has been excluded.
- •Age 13-18 years.
- •Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
- •Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.
排除标准
- •Children not fulfilling the inclusion criteria.
- •Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
- •Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
- •Children receiving other medication known to cause abdominal pain.
- •Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
- •Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
- •Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
- •Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
- •Children with a history of malignancy.
- •Pregnancy.
- •Children with history of allergy to maize or probiotics.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
VSL#3 90 billion bacteria
干预措施: VSL#3 90 billion bacteria (Drug)
VSL#3 900 billion bacteria
干预措施: VSL#3 900 billion bacteria (Drug)
结局指标
主要结局
The Gastrointestinal Symptom Rating Scale
时间窗: 8 weeks
次要结局
- Coddington life events questionnaire(8 weeks)
研究者
Sonia Michail, MD
Principal Investigator
Dayton Children's Hospital