Clinical trial NCT05035784: RCE With FMT in the Treatment of Childhood Constipation
Official title: Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Microbiota Transplantation
Constipation - Functional
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 4-14 years old;
* Roman IV criteria for childhood constipation;
* After a course of PEG and a course of Chinese medicine treatment was ineffective;
* Barium enema showing fecal impaction.

Exclusion criteria:

* Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors;
* Anorectal diseases, such as anal atresia, fistula, abscess, and tumor;
* Neurological diseases, such as brain and spinal cord diseases;
* genetic metabolic diseases;
* psychosocial and behavioral diseases;
* other systemic diseases;
* Refused to participate in.

Primary outcomes:
measure: improvement of spontaneous bowel movements(SBMs) per week
timeFrame: Baseline
measure: improvement of spontaneous bowel movements(SBMs) per week
timeFrame: at the end of 4-weeks FMT treatment
measure: improvement of spontaneous bowel movements(SBMs) per week
timeFrame: at the end of 12 weeks follow-up
measure: Satisfaction with bowel function
timeFrame: Baseline
measure: Satisfaction with bowel function
timeFrame: at the end of 4-weeks FMT treatment
measure: Satisfaction with bowel function
timeFrame: at the end of 12 weeks follow-up
Secondary outcomes:
measure: Bowel movements
timeFrame: Baseline
measure: Bowel movements
timeFrame: at the end of 4-weeks FMT treatment
measure: Bowel movements
timeFrame: at the end of 12 weeks follow-up
measure: Painful or hard bowel movements
timeFrame: Baseline
measure: Painful or hard bowel movements
timeFrame: at the end of 4-weeks FMT treatment
measure: Painful or hard bowel movements
timeFrame: at the end of 12 weeks follow-up
measure: Large diameter or scybalous stools
timeFrame: Baseline
measure: Large diameter or scybalous stools
timeFrame: at the end of 4-weeks FMT treatment
measure: Large diameter or scybalous stools
timeFrame: at the end of 12 weeks follow-up
measure: Excessive volitional stool retention
timeFrame: Baseline
measure: Excessive volitional stool retention
timeFrame: at the end of 4-weeks FMT treatment
measure: Excessive volitional stool retention
timeFrame: at the end of 12 weeks follow-up
measure: Encopresis
timeFrame: Baseline
measure: Encopresis
timeFrame: at the end of 4-weeks FMT treatment
measure: Encopresis
timeFrame: at the end of 12 weeks follow-up
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
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