跳至主要内容
临床试验/NCT05035784
NCT05035784已完成不适用

Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Satisfaction with bowel function

研究概览

简要总结

Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease.

Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.

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 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Fecal supernatant

Active Comparator

Fecal supernatant is used for treatment of childhood Constipation

干预措施: Fecal supernatant (Drug)

non-Fecal supernatant

Placebo Comparator

Placebo is used for treatment of childhood Constipation

干预措施: Placebo (Drug)

结局指标

主要结局

Satisfaction with bowel function

时间窗: at the end of 12 weeks follow-up

Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).

improvement of spontaneous bowel movements(SBMs) per week

时间窗: at the end of 12 weeks follow-up

the frequency of defecation without drugs or other auxiliary methods

次要结局

  • Large diameter or scybalous stools(at the end of 12 weeks follow-up)
  • Excessive volitional stool retention(at the end of 12 weeks follow-up)
  • Bowel movements(at the end of 12 weeks follow-up)
  • Painful or hard bowel movements(at the end of 12 weeks follow-up)
  • Encopresis(at the end of 12 weeks follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shucheng Zhang

professor

Shengjing Hospital

研究点 (1)

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