Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Number of Participants who no longer fulfill the Rome IV constipation criteria
研究概览
简要总结
The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.
详细描述
Constipation is a common condition in children which affects around 10% of the paediatric population. In 95 % cases it is a functional disorder of the digestive tract, without any organic cause. Recommendations of lifestyle modifications accompanying pharmacological treatment of constipation are very popular among healthcare providers, although there is limited data concerning non-pharmacological treatment methods of this condition. Adequate for age fluid intake is now recommended for patients with constipation. Further research is needed to form stronger recommendations in the future. The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with functional constipation diagnosed based on Rome IV criteria
排除标准
- •Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
- •Children who fulfil the criteria of Irritable Bowel Syndrome
- •Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
- •Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
- •Recurrent or unexplained fevers
- •History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
- •Concomitant use of drugs that are known to affect gastrointestinal motility
- •Established diagnoses of autism spectrum disorders
- •Mental retardation
- •Children who are exclusively breastfed
- •Non-retentive faecal incontinence
研究组 & 干预措施
Study Group
Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment
干预措施: Educational information (Behavioral)
Control Group
Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment
结局指标
主要结局
Number of Participants who no longer fulfill the Rome IV constipation criteria
时间窗: last week of intervention
Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.
次要结局
- Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention(8 weeks)
- Frequency (number per week) of bowel movements during the fourth and last weeks of intervention(8 weeks)
- Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention(8 weeks)
- Painful bowel movements (number per week) during the fourth and last weeks of intervention(8 weeks)
- Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention(8 weeks)
- Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention(8 weeks)
- Need for rescue laxative treatment during the intervention (number of cases)(8 weeks)
- Time (days) from the start of intervention needed to achieve treatment success.(8 weeks)
- Adverse events during intervention (number and type of reported adverse events)(8 weeks)
研究者
Piotr Dziechciarz, MD
Principal Investigator
Medical University of Warsaw