NCT05035784

RCE With FMT in the Treatment of Childhood Constipation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fecal Microbiota Transplantation
• Constipation - Functional

Interventions

Type	Name	Description
DRUG	Fecal supernatant	Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
DRUG	Placebo	a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.

Timeline

• Start date: 2020-11-10
• Primary completion: 2022-01-20
• Completion: 2022-05-13
• First posted: 2021-09-05
• Last updated: 2023-11-22

Locations

1 site across 1 country: China