The Role of Lactobacillus Reuteri in Nutritional Recovery and Treatment of Constipation in Children and Adolescents With Anorexia Nervosa - Randomised, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioGaia AB
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants That Drop Out From Rome III Criteria for Constipation
研究概览
简要总结
The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial role in treatment of children and adolescents with Anorexia nervosa who develop motility disorder due to the malnutrition regarding the normalization of the motility, as well as the possible role of probiotics on nutritional recovery, especially on bone health.
详细描述
Pediatric patients with AN and constipation referred to gastroenterologist for nutritional rehabilitation at the Department of Pediatric Gastroenterology, Hepatology and Nutrition, Clinical Hospital Center Sestre Milosrdnice, Zagreb, approximately 30 children, will be asked to participate.
The evaluation of patients will be conducted through APA DSM-V diagnostic criteria for anorexia nervosa and Rome III criteria for constipation.
During the hospitalization all of the patients will receive conventional nutritional rehabilitation that is composed of serving normal food under supervision of nurses that calculate daily caloric intake through 5-6 meals and according to that additional enteral nutrition that consist of polymeric enteral formula. Daily caloric intake is calculated as kcal/kg/day and is slowly rising through 2 weeks starting from 80% to the goal of 130% of daily energy requirements according to FAO 2004 recommendation.
Anthropometry measures will be taken at the time of hospitalization and at every visit.
Normalization of weight is when the Z-score for BMI is less than -1.5 according to CDC BMI-growth charts, or normalisation of menstrual cycle is achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years
排除标准
- •AN and constipation present for less than 3 month prior to hospitalization
- •any disease that affects GI or other systems other than AN or functional constipation
- •chronic disorder other than AN
- •receiving probiotic and/or prebiotic products 14 days prior to enrolment
- •receiving antibiotics 14 days prior to enrolment
- •constipation prior AN
- •receiving laxative as a therapy for constipation or abuse of laxative to lose weight prior to enrolment
- •extraintestinal symptoms: fever, rash
- •abnormalities in laboratory findings
- •abnormalities in clinical findings: organomegaly, perianal disease
结局指标
主要结局
Number of Participants That Drop Out From Rome III Criteria for Constipation
时间窗: 3 month
Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.
次要结局
- Normalization of Body Weight(6 month)