RCE With FMT in the Treatment of Childhood Constipation
Status:
Recruiting
Trial end date:
2022-03-03
Target enrollment:
Participant gender:
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.