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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.
Shengjing Hospital
Shenyang, Liaoning, China
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Time frame: Baseline
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Time frame: at the end of 4-weeks FMT treatment
improvement of spontaneous bowel movements(SBMs) per week
the frequency of defecation without drugs or other auxiliary methods
Time frame: at the end of 12 weeks follow-up
Satisfaction with bowel function
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).
Time frame: Baseline
Satisfaction with bowel function
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).
Time frame: at the end of 4-weeks FMT treatment
Satisfaction with bowel function
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).
Time frame: at the end of 12 weeks follow-up
Bowel movements
the frequency of bowel movements per week
Time frame: Baseline
Bowel movements
the frequency of bowel movements per week
Time frame: at the end of 4-weeks FMT treatment
Bowel movements
the frequency of bowel movements per week
Time frame: at the end of 12 weeks follow-up
Painful or hard bowel movements
The feelings of children during defecation
Time frame: Baseline
Painful or hard bowel movements
The feelings of children during defecation
Time frame: at the end of 4-weeks FMT treatment
Painful or hard bowel movements
The feelings of children during defecation
Time frame: at the end of 12 weeks follow-up
Large diameter or scybalous stools
appearance and wetness of stool
Time frame: Baseline
Large diameter or scybalous stools
appearance and wetness of stool
Time frame: at the end of 4-weeks FMT treatment
Large diameter or scybalous stools
appearance and wetness of stool
Time frame: at the end of 12 weeks follow-up
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Time frame: Baseline
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Time frame: at the end of 4-weeks FMT treatment
Excessive volitional stool retention
The number of children who intentionally control or reduce the frequency of defecation
Time frame: at the end of 12 weeks follow-up
Encopresis
the frequency of fecal incontinence
Time frame: Baseline
Encopresis
the frequency of fecal incontinence
Time frame: at the end of 4-weeks FMT treatment
Encopresis
the frequency of fecal incontinence
Time frame: at the end of 12 weeks follow-up
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