RCE With FMT in the Treatment of Childhood Constipation
- Conditions
- Fecal Microbiota TransplantationConstipation - Functional
- Interventions
- Drug: Fecal supernatantDrug: Placebo
- Registration Number
- NCT05035784
- Lead Sponsor
- Shengjing Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fecal supernatant Fecal supernatant Fecal supernatant is used for treatment of childhood Constipation non-Fecal supernatant Placebo Placebo is used for treatment of childhood Constipation
- Primary Outcome Measures
Name Time Method Satisfaction with bowel function 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 at the end of 12 weeks follow-up the frequency of defecation without drugs or other auxiliary methods
- Secondary Outcome Measures
Name Time Method Large diameter or scybalous stools at the end of 12 weeks follow-up appearance and wetness of stool
Excessive volitional stool retention at the end of 12 weeks follow-up The number of children who intentionally control or reduce the frequency of defecation
Bowel movements at the end of 12 weeks follow-up the frequency of bowel movements per week
Painful or hard bowel movements at the end of 12 weeks follow-up The feelings of children during defecation
Encopresis at the end of 12 weeks follow-up the frequency of fecal incontinence
Trial Locations
- Locations (1)
Shengjing Hospital
🇨🇳Shenyang, Liaoning, China