Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Increase in stool number/week to at least 4 bowel movements
研究概览
简要总结
Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.
详细描述
Functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. Constipation is defined by the Rome III criteria. The symptoms are difficult to treat in part of the patients and cause frustration to the patient and family.
Probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. A recent study revealed that the administration of Lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation.
The study goal is to evaluate Lactobacillus reuteri (Biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of Lactobacillus reuteri (Biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.
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, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the GI tract, with parents agreeing to participate in the study and signing an informed consent.
- •Chronic constipation defined by the Rome III criteria (Must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS:
- •Two or fewer defecations in the toilet per week.
- •At least 1 episode of fecal incontinence per week.
- •History of retentive posturing or excessive volitional stool retention.
- •History of painful or hard bowel movements.
- •Presence of a large fecal mass in the rectum.
- •History of large diameter stools that may obstruct the toilet).
- •Normal Thyroid function test and negative celiac serology (IgA or IgG in patients with IgA deficiency), and no evidence of elevated RAST test for milk.
- •Parents or tutors signed informed consent to the child's participation the study.
- •Willingness to comply with the protocol.
排除标准
- 未提供
结局指标
主要结局
Increase in stool number/week to at least 4 bowel movements
时间窗: 8 weeks
The measurement will be done by phone interview at week 1 and 3, and at clinic visits at week 2 and 4. A follow-up phone interview after the medication/placebo is stopped, at weeks 6 and 8 post enrolment.
次要结局
- Improved stool consistency- measured by Bristol Stool Scale(4 weeks)
- Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.(4 -8 weeks)
研究者
Batia Weiss
Director, Division of Pediatric Gastroenterology and Nutrition
Sheba Medical Center